TENAX THERAPEUTICS, INC. - Quarter Report: 2008 October (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934. |
For the quarterly period ended October 31, 2008
¨ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 002-31909
OXYGEN BIOTHERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware | 26-2593535 | |
(State or Other Jurisdiction of Incorporation or Organization) |
(I.R.S. Employer Identification No.) |
3189 Airway Avenue, Building C, Costa Mesa, California 92626
(Address of Principal Executive Office)
714-427-6363
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 (the Exchange Act) during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
YES x NO ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting Company. See the definitions of large accelerated filer, accelerated filer and smaller reporting Company in Rule 12b-2 of the Exchange Act.
Large accelerated filer ¨ | Accelerated filer ¨ | Non-accelerated filer ¨ | Smaller Reporting Company x | |||
(Do not check if a smaller reporting Company) |
Indicate by check mark whether the registrant is a shell Company (as defined in Rule 12b-2 of the Exchange Act).
YES ¨ NO x
The number of shares outstanding of each of the issuers classes of common stock as of October 31, 2008: 159,761,385 shares of common stock, par value $0.0001.
FORM 10-Q
OXYGEN BIOTHERAPEUTICS, INC.
Page | ||||
PART I. | FINANCIAL INFORMATION | |||
Item 1. Financial Statements | ||||
Consolidated Condensed Balance Sheets as of October 31, 2008 (unaudited) and April 30, 2008 |
3 | |||
4 | ||||
5 | ||||
8 | ||||
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations | 14 | |||
Item 4T. Controls and Procedures | 16 | |||
PART II. | OTHER INFORMATION | |||
Item 1. Legal Proceedings | 17 | |||
Item 1A. Risk Factors | 17 | |||
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds | 17 | |||
Item 3. Defaults Upon Senior Securities | 18 | |||
Item 4. Submission of Matters to a Vote of Security Holders | 18 | |||
Item 5. Other Information | 18 | |||
Item 6. Exhibits | 18 | |||
Signatures | 18 |
* | Item 3 of Part I is not included in this filing as it is not required for Smaller Reporting Companies as defined in Rule 12b-2 of the Exchange Act |
Part I-Financial Information
ITEM 1. | FINANCIAL STATEMENTS. |
OXYGEN BIOTHERAPEUTICS, INC.
(FORMERLY SYNTHETIC BLOOD INTERNATIONAL, INC.)
(A Development Stage Company)
CONSOLIDATED CONDENSED BALANCE SHEETS
October 31, 2008 |
April 30, 2008 |
|||||||
(Unaudited) | ||||||||
ASSETS | ||||||||
CURRENT ASSETS |
||||||||
Cash and cash equivalents |
$ | 5,204,555 | $ | 4,880,633 | ||||
Prepaid expenses |
18,353 | 72,084 | ||||||
Total current assets |
5,222,908 | 4,952,717 | ||||||
PROPERTY AND EQUIPMENT, net of accumulated depreciation of $631,870 and $599,448 |
168,813 | 177,605 | ||||||
DEBT ISSUANCE COSTS, net of accumulated amortization of $764,325and $213,234, respectively |
4,746,237 | 5,297,289 | ||||||
PATENTS, net |
86,569 | 129,102 | ||||||
LICENSING RIGHTS, net |
358,917 | | ||||||
OTHER ASSETS |
150,000 | | ||||||
$ | 10,733,444 | $ | 10,556,713 | |||||
LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) | ||||||||
CURRENT LIABILITIES |
||||||||
Accounts payable |
$ | 27,307 | $ | 63,907 | ||||
Accrued liabilities |
74,932 | 54,453 | ||||||
Related party payables |
| 103,000 | ||||||
Note payable |
| 43,631 | ||||||
Total current liabilities |
102,239 | 264,991 | ||||||
LONG TERM PORTION of convertible notes, net of debt discount of $19,183,377 and $19,716,686 , respectively |
1,643,992 | 539,786 | ||||||
Total liabilities |
1,746,231 | 804,777 | ||||||
COMMITMENTS AND CONTINGENCIES |
||||||||
STOCKHOLDERS EQUITY (DEFICIT) |
||||||||
Preferred stock, undesignated, authorized 10,000,000 shares; none issued or outstanding |
| | ||||||
Common stock, par value $.0001 per share; authorized 400,000,000 shares; issued and outstanding 159,761,385 and 146,405,576, respectively |
15,975 | 1,464,056 | ||||||
Additional paid-in capital |
54,872,893 | 46,029,242 | ||||||
Deficit accumulated during the development stage |
(45,901,655 | ) | (37,741,362 | ) | ||||
Total stockholders equity (deficit) |
8,987,213 | 9,751,936 | ||||||
$ | 10,733,444 | $ | 10,556,713 | |||||
See accompanying notes to consolidated condensed financial statements.
3
OXYGEN BIOTHERAPEUTICS, INC.
(FORMERLY SYNTHETIC BLOOD INTERNATIONAL, INC.)
(A Development Stage Company)
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
Period From May 26, 1967 (inception) to October 31, 2008 |
Three Months Ended October 31, |
Six Months Ended October 31, |
||||||||||||||||||
2008 | 2007 | 2008 | 2007 | |||||||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | ||||||||||||||||
OPERATING EXPENSES AND LOSSES |
||||||||||||||||||||
Research and development |
$ | 12,889,902 | $ | 224,169 | $ | 118,871 | $ | 532,457 | $ | 270,363 | ||||||||||
General and administrative |
23,836,679 | 2,120,582 | 178,628 | 4,939,163 | 392,114 | |||||||||||||||
Loss on impairment of long-lived assets |
39,225 | 7,112 | | 7,112 | | |||||||||||||||
Total operating expenses and losses |
36,765,806 | 2,351,863 | 297,499 | 5,478,732 | 662,447 | |||||||||||||||
INTEREST EXPENSE |
9,944,464 | 1,639,055 | 653,376 | 2,815,557 | 1,330,341 | |||||||||||||||
LOSS ON EXTINGUISHMENT OF DEBT |
250,097 | | | | | |||||||||||||||
OTHER INCOME AND GAINS |
(1,058,712 | ) | (78,840 | ) | (18,936 | ) | (133,996 | ) | (33,652 | ) | ||||||||||
NET LOSS |
$ | (45,901,655 | ) | $ | (3,912,078 | ) | $ | (931,939 | ) | $ | (8,160,293 | ) | $ | (1,959,166 | ) | |||||
NET LOSS PER SHARE, BASIC AND DILUTED |
$ | (0.0249 | ) | $ | (0.007 | ) | $ | (0.0372 | ) | $ | (0.005 | ) | ||||||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING, BASIC AND DILUTED |
157,194,649 | 140,518,275 | 219,278,696 | 140,319,577 | ||||||||||||||||
See accompanying notes to consolidated condensed financial statements.
4
OXYGEN BIOTHERAPEUTICS, INC.
(FORMERLY SYNTHETIC BLOOD INTERNATIONAL, INC.)
(A Development Stage Company)
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
Period from May 26, 1967 (inception) to October 31, |
Six months ended October 31, |
|||||||||||
2008 | 2007 | |||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | ||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES |
||||||||||||
Net loss |
$ | (45,901,655 | ) | $ | (8,160,293 | ) | $ | (1,959,166 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities |
||||||||||||
Depreciation and amortization |
1,472,474 | 50,475 | 33,356 | |||||||||
Amortization of deferred compensation |
336,750 | | | |||||||||
Interest on debt instruments |
9,554,374 | 2,815,558 | 989,837 | |||||||||
Bad debt expense |
12,500 | 12,500 | | |||||||||
Loss (gain) on debt settlement and extinguishment |
163,097 | | | |||||||||
Loss on impairment of long-lived assets |
39,225 | 7,112 | | |||||||||
Loss (gain)on disposal or assignment and write down of property and equipment and other assets |
192,683 | (26,622 | ) | | ||||||||
Issuance and vesting of compensatory stock options and warrants |
6,496,742 | 3,435,948 | 24,093 | |||||||||
Issuance of common stock below market value |
695,248 | | | |||||||||
Issuance of common stock as compensation |
72,660 | 60,200 | | |||||||||
Issuance of common stock for services rendered |
1,561,379 | 296,100 | | |||||||||
Issuance of note payable for services rendered |
120,000 | | | |||||||||
Contributions of capital through services rendered by stockholders |
216,851 | | | |||||||||
Changes in operating assets and liabilities |
||||||||||||
Prepaid expenses and other assets |
51,291 | 3,731 | 56,010 | |||||||||
Accounts payable and accrued liabilities |
177,833 | (259,121 | ) | 391,177 | ||||||||
Net cash used in operating activities |
(24,738,548 | ) | (1,764,412 | ) | (464,693 | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES |
||||||||||||
Purchase of property, equipment and other assets |
(1,191,479 | ) | (23,630 | ) | (8,335 | ) | ||||||
Capitalization of patent costs |
(764,152 | ) | (46,559 | ) | | |||||||
Purchase of licensing rights |
(23,470 | ) | (23,470 | ) | | |||||||
Net cash used in investing activities |
$ | (1,979,101 | ) | $ | (93,659 | ) | $ | (8,335 | ) | |||
See accompanying notes to consolidated condensed financial statements.
5
OXYGEN BIOTHERAPEUTICS, INC.
(FORMERLY SYNTHETIC BLOOD INTERNATIONAL, INC.)
(A Development Stage Company)
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS - CONTINUED
Period from May 26, 1967 (inception) to July 31, 2008 |
Six months ended October 31, |
|||||||||||
2008 | 2007 | |||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | ||||||||||
CASH FLOWS FROM FINANCING ACTIVITIES |
||||||||||||
Proceeds from sale of common stock and exercise of stock options and warrants, net of related expenses |
$ | 21,062,247 | $ | 2,225,624 | $ | | ||||||
Repayments of amounts due stockholders |
(121,517 | ) | | | ||||||||
Proceeds from stockholder notes payable |
977,692 | | | |||||||||
Proceeds from former and current officer loans |
39,500 | | 39,500 | |||||||||
Repayments of former and current officer loans |
(39,500 | ) | | | ||||||||
Proceeds from issuance of notes payable, net of issuance costs |
2,104,420 | | 418,025 | |||||||||
Proceeds from convertible notes, net of issuance costs |
8,807,285 | | | |||||||||
Payments on notes - short-term |
(616,614 | ) | (43,631 | ) | | |||||||
Payments on notes - long term |
(291,309 | ) | | | ||||||||
Net cash provided by financing activities |
31,922,204 | 2,181,993 | 457,525 | |||||||||
Net change in cash and cash equivalents |
5,204,555 | 323,922 | (15,503 | ) | ||||||||
Cash and cash equivalents, beginning of period |
| 4,880,633 | 16,234 | |||||||||
Cash and cash equivalents, end of period |
$ | 5,204,555 | $ | 5,204,555 | $ | 731 | ||||||
Cash paid for: |
||||||||||||
Interest |
$ | 241,855 | $ | | $ | | ||||||
Income taxes |
$ | 20,739 | $ | | $ | 3,719 | ||||||
See accompanying notes to consolidated condensed financial statements.
6
OXYGEN BIOTHERAPEUTICS, INC.
(FORMERLY SYNTHETIC BLOOD INTERNATIONAL, INC.)
(A Development Stage Company)
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS - CONTINUED
Non-cash financing activities during the six months ended October 31, 2008:
(1) | The Company issued 4,697,560 shares of common stock for the conversion of notes payable with a gross carrying value of $1,160,298, at a conversion price of $0.247 per share. These notes included discounts totaling $1,073,095, and thus had a net carrying value of $87,203. The unamortized discounts of $1,073,905 was recognized as interest expense upon conversion. |
(2) | As further discussed in Note 4, the Company entered into a license agreement in May 2008 with Virginia Commonwealth University (Licensor) whereby the Company obtained certain rights in connection with three of the Licensors patents. The purchase price of these licensing rights totaled $369,728, which included a $16,228 cash payment by the Company plus the issuance of five-year warrants to purchase 500,000 shares of common stock at $0.42 per share. These warrants were valued at $376,970. In connection with the license agreement, the Company also paid the Licensor $50,000 as a deposit towards future royalties. |
(3) | During the first six months of 2008, the Company received a total of $2,225,624 from the exercise of warrants. Due to errors made by the Company in the pricing of certain warrant exercise transactions, $140,000 of this total was owed back to the related investors. The Company paid off this obligation in the during this period and therefore there are no amounts related this obligation shown on the balance sheet.. Additionally, the Company is owed $12,500 for a similar warrant exercise pricing error with another investor. This amount has been expensed as a bad debt, as the Company does not intend to take further action to collect this receivable. |
(4) | The Company assigned patents related to their glucose monitoring technology with a total historical cost of $180,751 and accumulated amortization of $107,373 to Glucometrics, Inc for a 10 % interest in Glucometrics, Inc. and the right to receive royalty payments on revenues received by Glucometrics, Inc on any products developed using our patented technology. The total investment was recorded at $100,000 and we recognized a gain of $26,622 on the assignment of the patents to Glucometrics, Inc. |
Non-cash financing activities during the six months ended October 31, 2007:
In connection with the issuance of $282,055 of two-year notes payable, the Company recorded discounts on notes payable related to the original issue discount of $16,417, and additional discounts of $70,282 related to the relative fair value of 2,820,550 warrants issued in the transaction.
The Company made principal payments on its convertible notes payable of $72,000 through the issuance of 889,336 shares of common stock.
The Company recorded debt issue costs of $154,070 of which $63,542 was non-cash through the issuance of 2,820,550 warrants for capital raising services.
See accompanying notes to consolidated condensed financial statements.
7
OXYGEN BIOTHERAPEUTICS, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
1. BASIS OF PRESENTATION
Oxygen Biotherapeutics (the Company) was originally formed as a New Jersey corporation in 1967 under the name Rudmer, David & Associates, Inc., and subsequently changed its name to Synthetic Blood International, Inc. On June 17, 2008, the stockholders of Synthetic Blood International approved the Agreement and Plan of Merger dated April 28, 2008, between Synthetic Blood International and Oxygen Biotherapeutics, Inc., a Delaware corporation.
The accompanying unaudited consolidated condensed financial statements contain all adjustments (consisting only of normal recurring adjustments) which, in the opinion of management, are necessary to present fairly the financial position of the Company as of October 31, 2008, and the results of its operations for the six months ended October 31, 2008 and 2007, and for the period from May 26, 1967 (inception) to October 31, 2008, and its cash flows for the six months ended October 31, 2008 and 2007, and for the period from May 26, 1967 (inception) to October 31, 2008. Certain information and footnote disclosures normally included in financial statements have been condensed or omitted pursuant to rules and regulations of the U.S. Securities and Exchange Commission (the Commission). The Company believes that the disclosures in the financial statements are adequate to make the information presented not misleading. However, the financial statements included herein should be read in conjunction with the financial statements and notes thereto included in the Companys Annual Report on Form 10-K for the year ended April 30, 2008 filed with the Commission on August 13, 2008.
The accompanying consolidated condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. As shown in the accompanying financial statements, the Company is in the development stage and, at October 31, 2008, has an accumulated deficit of $45,901,655, continues to sustain operating losses on a monthly basis, and expects to incur operating losses for the foreseeable future. The Company requires substantial additional funds to complete clinical trials and pursue regulatory approvals. Although management believes that the Company has necessary working capital to fund operations in fiscal year 2008-2009, management is actively seeking additional sources of equity and/or debt financing; however, there is no assurance that any additional funding will be available.
In view of the matters described above, recoverability of a major portion of the recorded asset amounts shown in the accompanying October 31, 2008 balance sheet is dependent upon continued operations of the Company, which in turn is dependent upon the Companys ability to meet its financing requirements on a continuing basis, to maintain present financing, and to generate cash from future operations. These factors, among others, raise substantial doubt about the Companys ability to continue as a going concern. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts and classification of liabilities that might be necessary should the Company be unable to continue in existence.
2. RECENT ACCOUNTING PRONOUNCMENTS
In May 2008, the FASB issued Statement of Financial Accounting Standards No. 162, The Hierarchy of Generally Accepted Accounting Principles (SFAS 162). SFAS 162 identifies the sources of accounting principles and the framework for selecting the principles to be used in the preparation of financial statements of nongovernmental entities that are presented in conformity with generally accepted accounting principles in the United States. SFAS 162 will become effective 60 days following Securities and Exchange Commission (SEC) approval of the Public Company Accounting Oversight Board (PCAOB) amendments to AU Section 411, The Meaning of Present Fairly in Conformity With Generally Accepted Accounting Principles. The Company does not anticipate the adoption of SFAS 162 to have a material impact on its results of operations, financial position, or cash flows.
8
OXYGEN BIOTHERAPEUTICS, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS - CONTINUED
(UNAUDITED)
2. RECENT ACCOUNTING PRONOUNCMENTS (CONTINUED)
In June 2008, the FASB issued Staff Position No. EITF 03-6-1, Determining Whether Instruments Granted in Share-Based Payment Transactions Are Participating Securities (FSP EITF 03-6-1). FSP EITF 03-6-1 addresses whether instruments granted in share-based payment transactions are participating securities prior to vesting, and therefore, need to be included in the earnings allocation in calculating earnings per share under the two-class method described in FASB Statement of Financial Accounting Standards No. 128, Earnings Per Share. FSP EITF 03-6-1 requires companies to treat unvested share-based payment awards that have non-forfeitable rights to dividend or dividend equivalents as a separate class of securities in calculating earnings per shared. FSP EITF 03-6-1 is effective for fiscal years beginning after December 15, 2008. FSP EITF 03-6-1 is effective for the Company in the quarter ending July 31, 2009. The Company is currently assessing the impact of FSP EITF 03-6-1, but does not expect that such adoption will have a material effect on its results of operations, financial position, or cash flows.
In October 2008, the FASB issued Staff Position No EITF. 08-9, Milestones Method of Revenue Recognition (EITF 08-9). EITF 08-9 addresses the accounting when entities enter into revenue arrangements with multiple payment streams for a single deliverable or a single unit of accounting. The FASB staff could not reach agreement on transition of EITF 08-9. The Company does not anticipate the adoption of Staff Position No EITF 08-9 to have a material impact on its results of operations, financial position, or cash flows.
3. STOCK-BASED COMPENSATION
The fair value of the Companys stock options is determined using a Black-Scholes option pricing model, consistent with the provisions of SFAS No. 123R (Share-Based Payment) and Securities and Exchange Commission Staff Accounting Bulletin No. 107 (SAB 107). The fair value of stock options granted is recognized as compensation expense over the requisite service period. Compensation expense for all share-based payment awards is recognized using the straight-line single-option method. Effective May 1, 2006, the Company adopted SFAS No 123R, using a modified prospective application. Prior to May 1, 2006, the Company measured employee and board member compensation cost under the intrinsic method provided by Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB No. 25) whereby compensation expense is recognized for the excess, if any, of the fair value of the Companys common stock over the option price on the date the option is granted.
The Company uses the historical stock price volatility to value stock options within the Black-Scholes option pricing model. The expected term of stock options represents the period of time options are expected to be outstanding and is based on observed historical exercise patterns for the Company, which management believes are indicative of future exercise behavior. For the risk free interest rate, the Company uses the observed interest rates appropriate for the term that the options are expected to be outstanding.
The Companys net loss for the six months ended October 31, 2008 and 2007 includes approximately $1,552,415 and $24,093 of non-cash stock-based compensation costs. As of October 31, 2008, there was approximately $87,527 of total unrecognized compensation cost related to non-vested share-based compensation arrangements.
The fair value of each option grant during the six months ended October 31, 2008 was estimated at the grant date using the Black-Scholes option pricing model using the following assumptions: an average risk-free interest rate of 3.95%; average volatility of 105.34%; zero dividend yield for all years; expected life of 10 years; and an estimated forfeiture rate of 14.8%. There were 5,150,000 option grants during the six month period ending October 31, 2008.
The effect of potentially issuable shares of common stock was not included in the calculation of diluted loss per share given that the effect would be anti-dilutive.
4. LICENSING RIGHTS AND PATENTS
VCU License Agreement. In May 2008, the Company entered into a license agreement with Virginia Commonwealth University (Licensor) whereby Oxygen Biotherapeutics obtained a worldwide, exclusive license to valid claims under three of the Licensors patent applications that relate to methods for non-pulmonary delivery of oxygen to tissue and the products based on those valid claims used or useful for therapeutic and diagnostic applications in humans and animals. The license includes the right to sub-license to third parties. The term of the agreement is the life of the patents covered by the patent applications, except that we can terminate the agreement at any time on not less than 90 days advance notice.
The Company has an obligation to diligently pursue product development and also pursue new patent applications covered by this agreement; both at its own cost. The Company paid an initial fee of $50,000 in cash and paid an additional $23,470 to the Licensor as reimbursement of costs paid by the Licensor on patent applications and related work. The Company also issued to the licensor a warrant for the purchase of 500,000 shares of common stock at an exercise price of $0.42 per share that expires May 22, 2013. These warrants were valued at $353,500.
9
OXYGEN BIOTHERAPEUTICS, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS - CONTINUED
(UNAUDITED)
4. LICENSING RIGHTS AND PATENTS (CONTINUED)
The $50,000 initial fee is fully credited towards future royalty or sublicensing revenue payments to the Licensor. This fee has been accounted for as a deposit and is included in other assets at October 31, 2008.
The $23,470 reimbursement costs and the $353,500 value of the 500,000 warrants discussed above were capitalized as licensing rights and are being amortized over a period of ten years. Accumulated amortization on the licensing rights at October 31, 2008 totaled $18,054.
The Company agreed to pay to the Licensor a royalty on net sales of licensed products as follows:
Net Sales |
Applicable Royalty | ||
Up to $10 million |
25 | % | |
Over $10 million to $49 million |
15 | % | |
Over $49 million |
10 | % |
The Company also agrees to pay to the Licensor a percentage of sublicensing revenue received from sub-licensees or other third parties in regards to the licensed patents, equal to 33% of any such third party payments, which may be reduced to 25% if the Company completes pre-clinical studies on a licensed product, reduced further to 20% if the Company completes Phase I clinical studies, reduced further to 17% if the Company completes Phase II clinical studies, and reduced further to 10% if the Company completes Phase III clinical studies on a licensed product.
The Company agreed to pay a $20,000 annual maintenance fee to the Licensor, starting in May 2009 and payable in each following May as long as the agreement is in force. The maintenance fee payments will be fully credited towards future royalty or sublicensing revenue payments to the Licensor.
The Company agreed to pay a $50,000 annual minimum royalty to the Licensor, starting in May 2009 and payable in each following May as long as the agreement is in force. The minimum royalty fee payments will be fully credited towards future royalty or sublicensing revenue payments to the Licensor.
Lastly, the agreement provides that the Company will make the following minimum milestone payments to the Licensor, with respect to the first licensed product to achieve each milestone. However, if new licensed products are separately patentable, the same milestone payments shall apply to them.
Clinical Indication |
Medical Device | |
$25,000 upon filing of IND | $25,000 upon filing of FDA 510K or PMA | |
$100,000 upon completion of Phase I clinical trial | $250,000 upon receipt of FDA or foreign equivalent marketing approval | |
$200,000 upon completion of Phase II human clinical trial | ||
$300,000 upon completion of Phase III human clinical trial | ||
$500,000 upon receipt of FDA or foreign equivalent marketing approval |
As of October 31, 2008, the Company has not met any of the milestones identified above and therefore has not incurred any liabilities related to this licensing agreement.
Glucometrics License Agreement. In September 2008, the Company assigned all of its patent rights on glucose monitoring technology to Glucometrics, Inc. The agreement calls for Glucometrics, Inc to have exclusive rights to this technology for the entire life of the patent.. In exchange for the use of these patent rights the Company acquired a ten percent interest in Glucometrics, Inc and acquired the right to receive royalty payments on revenues generated by any product developed by Glucometrics that uses our glucose monitoring technology. The patents assigned to Glucometrics. Inc had a cost of $180,751 and had accumulated amortization of $107,373. The Company valued the entire investment in Glucometrics, Inc at $100,000 and has recognized a gain on the assignment of patent rights in the amount of $26,622. In the future, the Company will recognize in revenue any royalty payments received as part of this agreement. The company is accounting for this investment on the cost method of accounting. Management used Level 3 inputs, as defined by Financial Accounting Standard No. 157 Fair Value Measurements in order to value the Glucometrics investment, due to no observable market data. The transaction between the two companies is deemed to be an arms-length transaction.
The Glucometrics, Inc agreement calls for royalties to be paid to Oxygen Biotherapeutics, Inc as follows:
Net sales related to the marketing of an implantable licensed product:
Net Sales |
Applicable Royalty | ||
Up to $10 million |
10 | % | |
Over $10 million to $49 million |
8 | % | |
Over $49 million |
6 | % |
Net sales related to the marketing of a non-implantable licensed product:
Net Sales |
Applicable Royalty | ||
Up to $10 million |
8 | % | |
Over $10 million to $49 million |
6 | % | |
Over $49 million |
4 | % |
10
OXYGEN BIOTHERAPEUTICS, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS- CONTINUED
(UNAUDITED)
5. STOCKHOLDERS EQUITY
During the six months ended October 31, 2008:
(1) | The Company issued 4,697,560 shares of common stock for the conversion of notes payable with a gross carrying value of $1,160,298, at a conversion price of $0.247 per share. These notes included discounts totaling $1,073,095, and thus had a net carrying value of $87,203. The unamortized discounts of $1,073,095 were recognized as interest expense upon conversion. |
(2) | Pursuant to the exercise of warrants, the Company issued 7,845,000 shares and received a total of $2,225,624. Due to errors made by the Company in the pricing of certain warrant exercise transactions, $140,000 of this total is owed back to the related investors. The Company has included this obligation in current liabilities. Additionally, the Company is owed $12,500 for a similar warrant exercise pricing error with another investor. This amount has been expensed as a bad debt, as the Company does not intend to take further action to collect this receivable. |
(3) | The Company issued 84,000 shares of its common stock as compensation to its Chief Executive Officer, valued at $60,200. |
(4) | The Company issued 411,250 shares of its common stock to Fiona International at a price of .270 per share for a total value of $296,100 in payment of professional fundraising consultation services. |
(5) | The Company issued a total of 5,150,000 options to employees, including 4,000,000 to the CEO for services performed, with exercise prices ranging from $0.245 to $0.72 and all having a three-year term. The company charged approximately $1.4 million to compensation expense during the six months ended October 31, 2008 as a result of these issuances. |
On June 17, 2008, the stockholders of the Company approved the amendment of the Companys 1999 Stock Plan to increase the number of shares of common stock available for awards under the plan from 4,000,000 to 12,000,000, increase the maximum number of shares covered by awards granted under the plan to an eligible participant from 4,000,000 shares to 5,000,000 shares, and make additional technical changes to update the plan. Persons eligible to receive grants under the Plan consist of all of the Companys employees (including executive officers and employee directors), non-employee directors, and consultants and advisors who perform services for the Company.
The following table summarizes the Companys stock warrant information during the six month period ended October 31, 2008:
The six month period Ended October 31, 2008 | ||||||
Warrants | Weighted Average Exercise Price | |||||
Outstanding as of April 30, 2008 |
125,647,919 | $ | 0.25 | |||
Granted |
3,532,000 | 0.27 | ||||
Exercised |
(8,163,000 | ) | 0.27 | |||
Forfeited |
| | ||||
Outstanding as of October 31, 2008 |
121,016,919 | $ | 0.25 | |||
As of October 31, 2008, potentially issuable shares of common stock included 12,985,000 options, 121,016,919 warrants, and 77,312,445 conversion shares. Diluted earnings per share for the quarter ended October 31, 2008 was calculated assuming exercise of the above options and warrants and conversion of all of the outstanding convertible debt as of the beginning of the quarter. Upon conversion of the debt to common stock it is assumed that the Company would recognize $22,198,416 in additional interest expense for the write off of the related debt discounts and debt issuance costs.
6. RELATED PARTY TRANSACTIONS
During the six months ended October 31, 2008, the Company paid $87,000 in severance payments to Robert Nicora, a former President and Chief Executive Officer of the Company.
11
OXYGEN BIOTHERAPEUTICS, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS - CONTINUED
(UNAUDITED)
7. INCOME TAXES
In June 2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in Income Taxes, an Interpretation of FASB Statement No. 109. Interpretation No. 48 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The evaluation of a tax position in accordance with Interpretation No. 48 involves determining whether it is more likely than not that a tax position will be sustained upon examination, based upon the technical merits of the position. A tax position that meets the more-likely-than-not recognition threshold is measured to determine the amount of benefit to recognize in the financial statements. If a tax position does not meet the more-likely-than-not recognition threshold, the financial statements do not recognize a benefit for that position.
As required, the Company adopted Interpretation No. 48 during the quarter ended July 31, 2007. The adoption did not result in a material impact to The Companys results of operations or its financial condition.
The Company is subject to taxation in the U.S. and a small number of state jurisdictions. The material jurisdictions subject to potential examination by taxing authorities include the U.S. and California.
From time to time, The Company may be assessed interest or penalties by its tax jurisdictions, although any such assessments historically have been minimal and immaterial to The Companys financial results. In the event The Company has received an assessment for interest and/or penalties, it has been classified in the financial statements as general and administrative expense.
The utilization of net operating loss carry-forwards will likely be limited based on past and future issuances of common and preferred stock due to the ownership change provisions of Internal Revenue Code Section 382.
8. COMMITMENTS AND CONTINGENCIES
Employment AgreementsEffective March 25, 2008, Dr. Chris J. Stern, the Companys Chairman of the Board, was appointed to the office of Chief Executive Officer and will retain his position as Chairman. At the time Mr. Stern was elected to the Board in November 2007 and appointed Chairman, the Company agreed to pay to Mr. Sterns consulting firm a monthly fee of $15,000 for consulting services that Mr. Stern provides to the Company. Furthermore, the Company agreed (i) to issue to Mr. Stern, as of the date of his election to the Board, options to purchase 1,000,000 common shares at an exercise price of $0.245 per share that expire three years from the grant date, and (ii) if, in the two years following the date of the agreement, the Company enters into a license agreement or is sold, the Company will issue to Mr. Stern at the closing of the transaction, options to purchase an additional 4,000,000 common shares at an exercise price of $0.245 per share that expire three years from the grant date. As a result of Mr. Sterns appointment as Chief Executive Officer, the Board has agreed to pay Mr. Sterns consulting Company an additional $5,000 per month by way of consulting fees and also to pay the consulting Company $2,500 per month for additional secretarial and administration expenses. Furthermore, the Board has also agreed (i) to issue to Mr. Stern an aggregate of 14,000 shares of the Companys common stock on the 1st of every month, commencing with April 1, 2008, for so long as Mr. Stern serves on the Board, and (ii) to issue and pay to Mr. Stern, upon his termination as a board member by the Company for whatever reason, with or without cause, an aggregate of 100,000 shares of the Companys common stock and the sum of $200,000, payable upon such termination.
As a result of the Glucometrics, Inc licensing agreement Mr. Stern has met the requirements stated above and therefore has been issued 4,000,000 options to purchase common shares at an exercise price of $0.245. See footnote #5.
On February 1, 2000 the Board of Directors approved a two-year employment contract with Richard Kiral, as Vice President of Product Development. Mr. Kirals current base annual salary is $247,000 for the year ending April 2009 and includes an automobile allowance, medical and dental coverage, participation in the Executive Bonus Plan, $200,000 life insurance payable by the corporation and payable to a beneficiary named by the insured, and options granted for 75,000 shares annually. The contract will renew automatically annually unless terminated by either party. Mr. Kirals employment agreement provides that he is to receive a minimum severance payment equal to 9 months of his annual salary period in the event of a change in control as defined. Effective March 25, 2008, the Board appointed Dr. Richard M. Kiral to serve as President and Chief Operating Officer of the Company. Pursuant to an agreement executed on March 26, 2008, Dr. Kirals employment agreement with the Company has been amended., The Board has increased Dr. Kirals monthly compensation by $6,000 and has agreed to (i) to issue to Dr. Kiral an aggregate of 20,000 options to purchase shares of the Companys common stock, at a price to be determined, on the 1st of every month, commencing with April 1, 2008, for so long as Dr. Kiral serves on the Board, and (ii) to issue and pay to Dr. Kiral, upon his termination as a board member by the Company for whatever reason, with or without cause, an aggregate of 100,000 shares of the Companys common stock and the sum of $200,000, payable upon such termination.
Effective November 20, 2007, Robert W. Nicora, the Companys President, Chief Executive Officer and Chief Financial Officer resigned from all officer positions and from his directorship. In accordance with his employment agreement, Mr. Nicora is entitled to receive a total amount of $378,233 which includes accrued salaries, repayment of advances and severance payments. A total of $39,245 was paid on this obligation during the current six month period and the Company does not have any obligation on this agreement as of October, 31, 2008.
Effective September 26,2008, The Board of Directors approved the appointment of Charles H. Seeman to the position of Chief Financial Officer and Executive Vice President, Finance and Administration. In accordance with his employment agreement, Mr. Seeman is entitled to receive a base salary of $100,000, a $800 a month car allowance and upon approval of the Chief Executive Officer a grant to purchase 50,000 shares of the Company stock at a price to be determined on the grant date and additional grants of 50,000 shares each at each successful completion of each year of service. Mr. Seeman is also entitled to receive a bonus equal to 10 percent of his base salary for each year of service upon the approval of the Chief Executive Officer.
12
OXYGEN BIOTHERAPEUTICS, INC.
(A Development Stage Company)
NOTES TO CONSOLIDATED CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
8. COMMITMENTS AND CONTINGENCIES (CONTINUED)
Consulting AgreementsOn May 5, 2008 the Company entered into a consulting agreement with Fiona International SA for the provision of consulting services concerning licensing of the Companys Oxycyte product and other corporate matters. The agreement was effective through August 4, 2008, and involved the following remuneration: (a) Cash payments during the current quarter totaling $87,500; (b) the issuance of 3,032,000 five year common stock purchase warrants with an exercise price of $0.247 during the current quarter; (c) and the issuance of 411,250 shares of common stock on August 1, 2008. At October 31, 2008, the Company did not have any obligation under this agreement.
On September 11, 2008, the Company entered into a consulting agreement with Robert F. Diegelmann, Ph.D., Professor of Biochemistry, Anatomy and Emergency Medicine at Virginia Commonwealth University Medical Center. Dr. Diegelmann has agreed to conduct research, advance development, and assist with permitting for The Companys topical wound-healing therapy based on The Companys perfluorocarbon based oxygen carrier technology. The agreement is for a term of three years, and the Company has agreed to pay Dr. Diegelmann $9,000 per month for his services. The agreement also provides for additional incentive compensation. Upon successful registration of a 510K application for the first product, the agreement provides that the Company will issue to Dr. Diegelmann options to purchase 100,000 common shares under the Companys stock plan. In addition, the Company agreed to pay Dr. Diegelmann a success fee equal to one percent of net revenue from the Companys direct product sales. If the Company sells or licenses the product rights to a third party, the Company agrees to pay Dr. Diegelmann a transaction fee based on the aggregate consideration the Company receives, equal to five percent of the first $1,000,000, four percent of the next $1,000,000, three percent of the next $1,000,000, two percent of the next $1,000,000 and one percent for each $1,000,000 of consideration above $4,000,000 up to a maximum of $250,000.
The Company is preparing a 510K application that may be ready to file with the FDA in the first semester of 2009, and should that occur the Company would be obligated to issue Dr. Diegelmann options to purchase 100,000 shares of the Companys common shares.
Other AgreementsThe Company has entered into agreements with two of its Board members and a consultant whereby it will grant 3-year options for a total of 900,000 shares at an exercise of price of $0.30 per share in the event the Company enters into a license agreement, undergoes a change of control, or is sold.
As a result of the Glucometrics, Inc licensing agreement; Dr. Bruce Spies (board member), Dr. Gerry Klein (board member and Dr. Ross Bullock (consultant) received these options.
Registration RequirementWarrants totaling 49,410,844 and convertible notes with a face amount of $20,256,472 and conversion shares totaling 82,010,008 issued during the year ended April 30, 2008 are subject to a requirement that the Company file a registration statement with the SEC to register the underlying shares, and that it be declared effective on or before January 9, 2009. In the event that the Company does not have an effective registration statement as of that date, or if at some future date the registration ceases to be effective, then the Company is obligated to pay liquidated damages to each holder in the amount of 1% of the aggregate market value of the stock, as measured on January 9, 2009 or at the date the registration statement ceases to be effective. As an additional provision for non-registration of the shares, the holders would also receive the option of a cashless exercise of their warrant or conversion shares. During the first quarter of its fiscal 2009, the Company filied an registration statement, however, the Company has withdrawn the registration statement and is currently in the process of resolving the registration requirement issue with the holders of the notes and warrants.
The agreement underlying the issue of the above warrants (Warrant Agreement) asserts that, prior to September 30, 2008, The Company is required to take action to submit to the shareholders of The Company a proposal to amend The Companys articles of incorporation to increase the number of authorized shares of common stock by such amount as is necessary to reserve for issuance the maximum aggregate number of warrant shares then issued or potentially issuable in the future upon exercise of the Warrant Agreement. As a result of the June 30, 2008 merger (further described in Note 9), this action was completed and the number of authorized common shares was increased from 200 million common shares, par value $0.01, to 400 million common shares, par value $0.0001.
9. MERGER
On June 17, 2008, the stockholders of Synthetic Blood International, Inc. approved the Agreement and Plan of Merger dated April 28, 2008 (Plan of Merger), between Synthetic Blood International and Oxygen Biotherapeutics, Inc., a Delaware corporation. Oxygen Biotherapeutics was formed on April 17, 2008, by Synthetic Blood International to participate in the merger for the purpose of changing the state of domicile of Synthetic Blood International from New Jersey to Delaware. Certificates of Merger were filed with the states of New Jersey and Delaware, and the merger was effective June 30, 2008. Under the Plan of Merger, Synthetic Blood International has been merged with and into Oxygen Biotherapeutics, which is the surviving corporation. As a result of the merger: (a) Each share of Synthetic Blood International common stock outstanding on June 30, 2008, has been converted to one share of Oxygen Biotherapeutics common stock; (b) The name of the corporation is changed to Oxygen Biotherapeutics, Inc.; (c) The number of authorized common shares changed from 200,000,000 common shares, par value $0.01, to 400,000,000, par value $0.001; (d) The Certificate of Incorporation and Bylaws of Oxygen Biotherapeutics are now the charter documents for the corporation; and (e) The General Corporation Law of the State of Delaware now applies to the corporation, rather than the New Jersey Business Corporation Act.
10. SUBSEQUENT EVENTS
On October 23, 2008 Company representatives and representatives of the United States Food and Drug Administration (FDA) met to discuss the how the Company can proceed in the indication of Oxycete ® as a treatment for traumatic brain injury (TBI). As a result of this meeting, the Company is planning to propose a revision in the planned phase II-B study to make it a dose escalation study. The new study format allows the Company and the FDA to gain a better understanding of how perfluorocarbons react in the human body.
In November, 2008, the Company granted Charles H. Seeman, CPA, The Chief Financial Officer and Executive Vice President Finance and Administration, options to purchase and additional 50,000 shares of the Companies common stock under the bonus plan in his employment agreement.
On December 2, 2008 the Company announced a broad product development plan that included a wound product to be introduced to the consumer market.
In December, 2008, the Company withdrew the registration statement required by the convertible notes and is currently in the process of resolving the registration requirement issue with the holders of the notes and warrants.
13
ITEM 2. | MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. |
Overview
Since 1990, Oxygen Biotherapeutics has pursued the development of medical products based on perfluorocarbon technology. These products include Oxycyte, a synthetic oxygen carrier substance, and Fluorovent, an oxygen exchange fluid for facilitating the treatment of lung conditions. Since 1993 Oxygen Biotherapeutics has also pursued development of a glucose biosensor implant, which we recently licensed to a third party for development. In September 2008 we engaged a researcher to pursue application of the same perfluorocarbon oxygen carrier technology to development of topical wound healing therapies.
The nature of our business is to spend years in development and testing of pharmaceutical and medical device products, take products through a lengthy and expensive process of regulatory review by the FDA, and, if successful in showing the product is efficacious and obtaining FDA approval, commercialize the product. During the periods of development and regulatory review we have no product to sell and no revenue. Nevertheless, we incur substantial costs pursuing this process, which requires cash that comes from outside sources. We rely on outside financing to fund our operations, and will for the foreseeable future. That means we must continue to show progress with our products and be able to locate investors willing to commit their funds to a speculative venture that will ultimately be successful only if we can actually bring a product to market and gain a meaningful level of market acceptance and penetration. Because of these factors a larger number of biotechnology products under development fail, and there is no assurance that the products we have under development will not suffer the same fate.
We received approval of the Investigational New Drug application we filed with the FDA on Oxycyte and began Phase I clinical tests in October 2003. We completed the clinical tests in December 2003. The results of the Phase I tests were in line with our safety and efficacy expectations for the performance of Oxycyte. We started Phase II testing in 2004.
Five clinical sites received local Institutional Review Board approval to participate in the first Phase II trial with Oxycyte in hip surgery patients. In this first Phase II trial we were evaluating both efficacy and safety in the prevention of tissue hypoxia (the effects of reduced oxygen levels) in hip surgery patients who experience mild to moderate blood loss during surgery. We closed this study in 2006 due to a lack of enrollment.
A Phase II-A trial in severe brain injury patients was started in 2006 and has been completed with good results. The Phase II-B trial protocol was filed in April 2008. In October 2008, we met with the FDA regarding the trial protocol. The FDA requested additional information on the patient experience of the participants in the Phase II-A trial for purposes of evaluating potential side-effects associated with the use of Oxycyte, including thrombocytopenia, which is a deficiency of platelets in the blood that could then cause bleeding into the tissues, bruising and or slow blood clotting after injury. We are collecting the information and intend to resubmit the Phase II-B protocol to the FDA for approval, which may also include an additional proposal for conducting a dosing study. If the dosing study shows lower doses of Oxycyte can achieve acceptable therapeutic results, and concerns the FDA has with respect to side effects may be ameliorated. Our objective is to file the revised Phase II-B protocol in the first quarter of calendar year 2009. We have also been working on a Phase II protocol for a study in patients with sickle cell pain crisis to be filed with the FDA, but we do not plan on pursuing that filing until our Phase II-B protocol for brain injury is approved by the FDA. Our future plans include testing Oxycyte in stroke, myocardial infarction, malignant tumors, trauma, coronary bypass surgery and decompression sickness. We expect Phase II studies will continue through the end of 2010, at a minimum, after which Phase III studies may be able to commence depending on results of Phase II trials, the development of acceptable protocols for Phase III trials, and the availability of financial and other resources to pursue the Phase II trials.
While pursuing Oxycyte, we are increasing our focus on a new application of perfluorocarbon oxygen carrier technology to therapies applied to the skin, rather than infused, for treating wounds and abrasions. To that end we recently licensed certain technology related to that application from Virginia Commonwealth University and engaged the services of an independent consultant to pursue research and development of the therapies.
Fluorovent is still at the animal testing stage and we have not filed any applications with the FDA for human testing of this product. Since we will likely devote less of our time and resources to advancing this product because of the priority placed on Oxycyte and topical therapies, we do not expect we will be in a position to file any application for this product with the FDA in the near future. Since our priority for the foreseeable future is Oxycyte and topical wound therapy, the following discussion of our business focuses primarily on those products.
Our biosensor implant is still at the animal testing stage of development and we have not filed any applications with the FDA for human testing. Since we do not expect to commit significant resources to development of this technology in the foreseeable future, we recently licensed the technology to an unrelated party who is more focused on research and development in the area of glucose testing and related technologies.
Results of operations three-months and six-months ended October 31, 2008 compared to three-months and six-months ended October 31, 2007
Research and Development expenses for the three months ended October 31, 2008 were $224,169 compared to $118,871 for the same period in the prior year. This increase was due to additional costs related to conducting the Phase II-A and Phase II-B study in Traumatic Brain Injury (TBI) (increase of $59,587, costs related to the use of research and development specialists on a contract basis to assist the Company in conducting the Phase II-A and Phase II-B studies mentioned above. For the six months ended October 31, 2008, research and development costs were $532,457 compared to $270,363 for the same period in the prior year, Again the majority of the increase in total costs from period to period is due largely to an acceleration of the Oxycete ® development program. Both the three-month and six-month increases in total cost was financed by the latest round of convertible debenture issuance by the Company.
All Phase II related expenses for the three-month and six-month periods ended October 31, 2008, totaled approximately $49,070 and $81,767 respectively, compared to $800 for both comparable periods in 2007. Laboratory supplies for the three-month and six-month periods ended October 31, 2008, were $34,553 and $42,000, respectively, compared to $1,750 for both comparable periods in 2007. Consulting fees for our clinical studies contributed approximately $17,483 to our expenses during the quarter ended October 31, 2008, and $38,053 during the six months ended October 31, 2008, but during the six-month period ended October 31, 2007, there were no consulting fees associated with our clinical trials. Additionally, we incurred approximately $0 in contract manufacturing costs for Oxycyte and approximately $14,545 of equipment rental costs in the second quarter ended October 31, 2008, and approximately $19,700 in contract manufacturing costs and approximately $29,299 of equipment rental costs for the six-month period ended October 31, 2008, none of which we incurred in the six-month period ended October 31, 2007 Because of the nature of our ongoing research and development activities and depending on our cash flow levels, accounting periods may reflect significant changes in expenses resulting from the timing of research related to our developmental products.
General and Administrative expenses for the three months ended October 31, 2008 were $2,120,582, compared to approximately $178,628 for the same period in the prior year. $1,970,285 of this increase is due to the use of specialized management consultants retained under contract management agreements $1,484,429 of this increase is due to costs related to the issuance of stock options, $1,970,285 of this increase is due to the use of specialized management consultants retained under contract management agreements, and approximately $295,187 in increases to other costs related to General and Administrative expenses. General and
14
Administrative expenses for the six months ended October 31, 2008 were $4,939,163, compared to approximately $392,114 for the same period in the prior year. Approximately $2,288,421 of this increase is due to the use of specialized management consultants retained under contract management agreements, approximately $1,528,330 of this increase is due to costs related to the issuance of stock options, approximately $114,140 of this increase is due to costs related to investor relations. The remaining $616,158 was due to increases in various other General and Administrative related expenses.
The net loss for the three months ended October 31, 2008 was $3,912,078 compared to a net loss of $931,939 for the same period in the prior year, and the net loss for the six months ended October 31, 2008 was $8,160,293 compared to a net loss of $1,959,166 for the same period in 2007. In addition to the items noted above, interest expense increased approximately $985,679 during the three months ended October 31, 2008 over the comparable period in 2007, to a total of $1,639,055 in interest expense during the quarter. Interest expense increased approximately $1,485,226 during the six months ended October 31, 2008 over the comparable period in 2007, to a total of $2,815,557 in interest expense during the comparable period in 2007. A significant portion of these increases in interest expense are attributable to the sale of convertible notes, with a total face value of $14,077,778, in the third and fourth quarters of fiscal year 2008.
Liquidity, capital resources and plan of operation
We have financed our operations since September 1990 through the issuance of debt and equity securities and loans from stockholders. As of October 31, 2008, we had $5,222,908 of total current assets and working capital of $5,120,669. Our practice is to invest excess cash, where available, in short-term money market investment instruments.
During the third quarter of fiscal year 2008, the Company exchanged its outstanding short term loans for five-year convertible notes with a face amount of $6,204,767. The notes are unsecured, convertible into shares of common stock at $0.247 per share, and were issued with a 55% original issue discount totaling $3,412,622. In addition, the Company issued five-year warrants to purchase 12,560,257 shares of common stock at $0.247 per share to investors. Additional discounts of $1,739,499 and $1,052,646 were recorded for the relative fair values of the warrants and beneficial conversion feature, respectively. Pursuant to this exchange transaction, the Company recorded a debt extinguishment loss of $250,097.
During the third and fourth quarters of fiscal year 2008, the Company received a total of $6,335,000 in cash from the sale of convertible notes, with a total face amount of $14,077,778. The notes are convertible at any time prior to maturity into a total of 56,995,053 shares of common stock, or at a conversion rate of $0.247 per share. In connection with the issuance of these obligations, the Company recorded a 55% original issue discount of $7,742,778, and additional discounts of $4,864,998 related to the relative fair value of the 28,497,501 five-year warrants to purchase common stock at $0.247 per share that were issued in the transaction, and $1,470,002 for the relative fair value of the embedded beneficial conversion feature. The Company also incurred total costs of $5,510,562 for capital raising services on these transactions. The costs of the capital raising services include a $369,215 cash fee, plus $768,337 for the fair value of 2,088,272 restricted shares of common stock, plus $4,373,010 for the fair value of warrants to purchase 21,853,086 common shares at prices ranging from $0.20 to $0.28.
During the six months ended October 31, 2008, net cash provided by financing activities was $2,181,993, which included $ 2,225,624 proceeds from the exercise of warrants, less $43,631 in repayments on a short term note. Of the $ 2,225,624 proceeds received from warrant exercises, we returned $140,000 due to a pricing error in the exercise. Net cash of $ 2,518,373 was used to fund operating activities and $ 93,659 was used for investing activities, which included $11,466 in lab equipment expenditures, $ 70, 028 for the purchase of licensing rights on three patents and other patent additions, and the remaining $12,165 on other equipment. Consequently, our cash and cash equivalents increased from $4,880,633 at April 30, 2008 to $5,204,555 at October 31, 2008. We do not have any lines of credit or other borrowing arrangements with lenders.
We are in the pre-clinical and clinical trial stages in the development of our products. Under an Investigational New Drug application filed with the FDA, we completed Phase I clinical studies on Oxycyte in December 2003. The results of the Phase I study were in line with our expectations for the performance of Oxycyte. We submitted a report to the FDA along with a Phase II protocol, received FDA approval, and started Phase II testing in the fourth quarter of 2004, which is expected to continue through 2009 for Phase II-b studies in severe traumatic brain injury. Even if we are successful with our Phase II study, we must then conduct a Phase III clinical study and, if that is successful, file with the FDA and obtain approval of a Biologics License Application to begin commercial distribution, all of which will take more time and funding to complete. Our other products, Fluorovent and the glucose biosensor, must undergo further development and testing prior to submission to the FDA for approval to initiate clinical trials, which also requires additional funding. Management is actively pursuing private and institutional financing, as well as strategic alliances and/or joint venture agreements to obtain the necessary additional financing and reduce the cost burden related to the development and commercialization of our products. We expect our primary focus will be on funding the continued testing of Oxycyte, since this product is the furthest along in the regulatory review process. Our ability to continue to pursue testing and development of our products beyond 2009 depends on achieving license income, or obtaining outside financial resources. There is no assurance that needed license agreement, or financing will occur or that we will succeed in obtaining the necessary resources.
We are entirely dependent on outside financing to continue our operations. We will not generate operating revenue unless and until one of our products is approved for commercial sale and sales activity begins. We will require substantial additional funds to complete clinical trials, pursue regulatory approval for our products, establish commercial scale manufacturing capabilities, and establish marketing, sales, and administrative capabilities. Expenditures for these purposes will result in substantial losses for at least the next several years. The expense and the time required to realize any product revenues or profitability are highly uncertain. We cannot ensure that we will be able to achieve product revenues or profitability on a sustained basis, or at all. The foregoing factors highlight that the Company must achieve license agreements, or additional financing by end of 2009.
We do have the working capital necessary to fund our operations in fiscal year 2009. We believe that as early as July 31, 2009, latest end of 2009 we will need additional financing to cover administrative expenses and on-going expenses of testing Oxycyte. Management is actively seeking additional sources of equity and/or debt financing; however there is no assurance that any additional funding will be available in time. Furthermore, management is hoping to generate income in 2009. Should we be unable to obtain additional financing, or income, to meet mid-term needs, we may be forced to cease operations. Our ability to continue as a going concern depends on success of these activities.
CRITICAL ACCOUNTING POLICIES
Our discussion and analysis of our financial condition and results of operations is based upon the financial statements presented in this report, which have been prepared in accordance with Accounting Principles Generally Accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent liabilities. On an on-going basis, we evaluate our estimates, including those related to stock-based compensation and contingencies. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements:
15
Stock-Based CompensationWe account for stock-based compensation as prescribed by of SFAS No. 123R, which requires stock options and warrants issued to employees and nonemployees to be valued using the fair value method. Under the fair value based method, compensation cost is recorded based on the value of the award at the grant date and is recognized over the service period.
The fair value of each option and warrant grant was estimated at the grant date using the Black-Scholes option-pricing model. The BlackScholes option valuation model was developed for use in estimating the fair value of traded options and warrants that have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility and expected term.
Convertible NotesIf the conversion feature of conventional convertible debt provides for a rate of conversion that is below market value, this feature is characterized as a beneficial conversion feature (BCF). A BCF is recorded by the Company as a debt discount pursuant to EITF Issue No. 98-5 (EITF 98-05), Accounting for Convertible Securities with Beneficial Conversion Features or Contingency Adjustable Conversion Ratio, and EITF Issue No. 00-27, Application of EITF Issue No. 98-5 to Certain Convertible Instruments. In those circumstances, the convertible debt will be recorded net of the discount related to the BCF. The Company amortizes the discount to interest expense over the life of the debt using the effective interest method.
Registration Payment ArrangementsIn connection with prior private placements of our common stock and warrants to purchase shares of our common stock, we entered into agreements that committed us to timely register the shares of common stock purchased as well as the shares underlying the issued warrants. Those registration agreements specified potential cash penalties if we did not timely register the related shares with the SEC.
In accordance with EITF 00-19, Accounting for Derivative Financial Instruments Indexed To, and Potentially Settled In a Companys Own Stock, when the potential cash penalties were included in registration payment arrangements, the estimated fair value of the warrants would be recorded as a liability, with an offsetting reduction to additional paid-in capital received from the private placement. The fair value of the warrants would be estimated using the Black-Scholes option pricing model.
Under EITF 00-19, the estimated fair value of the warrants would be re-measured at each reporting date and on the date of effectiveness of the related registration statement, with the increase in fair value recorded as other expense in our Statement of Operations. As of the date of effectiveness of the registration statement, the warrant liability would be reclassified to additional paid-in capital, evidencing the non-impact of these adjustments on our financial position and business operations.
In December 2006, the FASB issued FASB Staff Position, or FSP, EITF No. 00-19-2, Accounting for Registration Payment Arrangements. This FSP specifies that companies that enter into agreements to register securities will be required to recognize a liability if a payment to investors for failing to fulfill the agreement is probable and can be reasonably estimated. This accounting differs from the guidance in EITF 00-19, which required a liability to be recognized and measured at fair value, regardless of probability.
EITF 00-19-2 is effective immediately for registration payment arrangements and the financial instruments subject to those arrangements that we enter into or modify after the date of issuance of this FSP. For our registration payment arrangements and financial instruments subject to those arrangements that were entered prior to the issuance of this FSP, the guidance was effective beginning January 1, 2007.
Long-Lived Assets Our intangible assets consist of patents related to our various technologies. These assets are amortized on a straight-line method over their estimated useful life, which ranges from eight to ten years. We review these intangible assets for impairment in accordance with SFAS No.144, Accounting for the Impairment or Disposal of Long-Lived Assets (SFAS 144).
FORWARD LOOKING STATEMENTS
Except for the historical information contained herein, the discussion and information presented in this report contain forward-looking statements that involve risks and uncertainties. Oxygen Biotherapeutics actual results could differ materially from those presented in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in this section and those discussed in the Oxygen Biotherapeutics Annual Report on Form 10-K for the year ended April 30, 2008 and subsequent filings made with the Securities and Exchange Commission.
Although Oxygen Biotherapeutics believes that the expectations reflected in the forward-looking statements are reasonable, Oxygen Biotherapeutics cannot guarantee future results, levels of performance or achievements. Moreover, neither Oxygen Biotherapeutics nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Oxygen Biotherapeutics is under no obligation to update any of the forward-looking statements after the filing of this report to conform such statements to actual results or changes in expectations.
ITEM 4T. | CONTROLS AND PROCEDURES |
This Report includes the certifications of our Chief Executive Officer and Chief Financial Officer required by Rule 13a-14 of the Securities Exchange Act of 1934 (the Exchange Act). See Exhibits 31.1 and 31.2. This Item 4T includes information concerning the controls and control evaluations referred to in those certifications.
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures, as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934 (the Exchange Act), are designed to ensure that information required to be disclosed in reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in rules and forms adopted by the Securities and Exchange Commission (SEC), and that such information is accumulated and communicated to management, including the Chief Executive Officer and the Chief Financial Officer, to allow timely decisions regarding required disclosures.
In connection with the preparation of this report, Oxygen Biotherapeutics management, under the supervision and with the participation of the Chief Executive Officer and Chief Financial Officer, assessed the effectiveness of the design and operation of our disclosure controls and procedures as of October31, 2008. Because of the material weaknesses in our internal control over financial reporting described below, our Chief Executive Officer and Chief Financial Officer conclude that our disclosure controls and procedures were not effective as of October 31, 2008.
Material Weaknesses
In our annual report on Form 10-K for the year ended April 30, 2008, we reported that our disclosure controls and procedures were not effective as of April 30, 2008, because of material weaknesses in our internal control over financial reporting. A material weakness is defined under SEC rules as a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of a Companys annual or interim
16
financial statements will not be prevented or detected on a timely basis by the Companys internal controls. As a result of managements review and evaluations that were completed after the end of fiscal year 2008 related to the preparation of managements report on internal controls over financial reporting required for this annual report on Form 10-K, management concluded that we had material weaknesses in our control environment and financial reporting process consisting of the following:
| We have incompatible duties in our cash disbursement process. Due to our small staff and historically limited financing, our President has had to maintain responsibility for check signing and authorizing invoices and purchase orders. |
| We have not always consistently maintained final, complete and executed copies of significant contracts, including financing agreements, warrant and option agreements, and note agreements. We rely on a very small staff, and have been a party to numerous complex financing transactions that required significant changes to terms, which were not clearly and effectively processed and recorded as they occurred. |
| Given our cash position for most of fiscal year 2008 and the limited number of accounting resources available to us, we did not maintain sufficient accounting personnel knowledgeable in US Generally Accepted Accounting Principles, did not measure board committee performance against established charters, have not implemented an anonymous whistle-blower process, and did not utilize a formal financial reporting close process that ensured sufficient levels of review of all key financial statement account reconciliations, significant judgments/estimates and period end financial statements. |
Managements conclusions regarding material weaknesses disclosed in our Form 10-K for the year ended April 30, 2008, were reached at the end of the first quarter of fiscal year 2009. Following the end of the first quarter, our management has pursued, and will continue to pursue, implementation of corrective measures to address the material weaknesses described above. These measures, outlined below, are intended both to address the identified material weaknesses and to enhance our overall financial control environment.
| We are adding administrative staff. The addition of administrative staff will facilitate the design and implementation of document collection and retention procedures with respect to the agreements and documents generated in our financing and business activities. |
| In fiscal year 2009 the Board of Directors intends to review existing committee charters, implement evaluation programs called for by the charters, and evaluate what changes, if any, are necessary or appropriate to make the functioning of Board committees more effective and meaningful. |
| We will examine options for an anonymous whistle blower process or system that is practical and meaningful in light of the fact that we have only four full-time employees who do have regular access to, and communication with, our executive officers and directors. |
We believe the remediation measures described above will, if we can effectively implement the measures, remediate the material weaknesses we have identified and strengthen our internal control over financial reporting. We are committed to continuing to improve our internal control processes and will continue to diligently and vigorously review our financial reporting controls and procedures. As we continue to evaluate and work to improve our internal control over financial reporting, we may determine to take additional measures to address control deficiencies or determine to modify, or in appropriate circumstances not to complete, certain of the remediation measures described above.
Changes in Internal Controls
There were no changes in Oxygen Biotherapeutics internal control over financial reporting during the three month period ended October 31, 2008, that materially affected, or are reasonably likely to materially affect, its internal control over financial reporting, except that we have hired a Chief Financial Officer that has helped us to achieve a better segregation of duties in our cash disbursement process and added a person to executive management with knowledge of US Generally Accepted Accounting Principles.
Part II-Other Information
ITEM 1. | LEGAL PROCEEDINGS |
Oxygen Biotherapeutics is not presently involved in any legal proceedings and was not involved in any such proceedings during the six month period ended October 31, 2008.
ITEM 1A. | RISK FACTORS |
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by Oxygen Biotherapeutics, except where such statements are made in connection with an initial public offering. All statements, other than statements of historical fact, which address activities, actions, goals, prospects, or new developments that we expect or anticipate will or may occur in the future, including such things as expansion and growth of our operations and other such matters are forward-looking statements. Any one or a combination of factors could materially affect our operations and financial condition. These factors include progress in our product development and testing activities, obtaining financing for operations, development of new technologies and other competitive pressures, legal and regulatory initiatives affecting our products, and conditions in the capital markets. Forward-looking statements made by us are based on knowledge of our business and the environment in which we operate as of the date of this report. Because of the factors discussed in the 2008 Annual Report on Form 10-K and in subsequent reports on Form 10-Q, actual results may differ from those in the forward-looking statements.
ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS |
In October 2008, Oxygen Biotherapeutics issued 3,132,879 shares of common stock to a convertible note holder upon the conversion of a previously outstanding convertible note in the principal amount of $773,822. In September 2008, Oxygen Biotherapeutics issued 99,183 shares of common stock to a convertible note holder upon the conversion of a previously outstanding convertible note in the principal amount of $24,498. In August 2008 Oxygen Biotherapeutics issued 89,968 shares of common stock to a convertible note holder upon the conversion of a previously outstanding convertible note in the principal amount of $22,222. The securities were issued in reliance on the exemption from registration set forth in Section 3(a)(9) of the Securities Act of 1933.
17
Oxygen Biotherapeutics issued 14,000 common shares at the beginning of each month from August through December 2008 (a total 70,000 shares of common stock) to Chris J. Stern, its Chief Executive Officer, valued at $36,120, pursuant to the terms of the compensation arrangement for Mr. Stern. The securities were issued in reliance on the exemption from registration set forth in Section 4(2) of the Securities Act of 1933.
Oxygen Biotherapeutics issued to Richard Kiral, its Chief Operating Officer, options to purchase 20,000 shares at the beginning of each month from August through December 2008 pursuant to the terms of the compensation arrangement for Mr. Kiral. The exercise prices range from $0.42 to $0.72, and the options expire 3 years following the date of issuance. Oxygen Biotherapeutics issued to Joan Mahan, its corporate secretary, options to purchase 10,000 shares at the beginning of each month from August through December 2008 pursuant to the terms of the compensation arrangement for Ms. Mahan. The exercise prices range from $0.42 to $0.72, and the options expire 3 years following the date of issuance. The foregoing securities were issued in reliance on the exemption from registration set forth in Section 4(2) of the Securities Act of 1933.
Oxygen Biotherapeutics issued to Chris Stern, its Chief Executive Officer, options to purchase 4,000,000 shares as a result of the signed license agreement with Glucometrics, pursuant to the terms of the compensation arrangement for Mr. Stern. The exercise price is $0.245 and the options expire 3 years following the date of issuance.
Oxygen Biotherapeutics also issued to employees and officers, options to purchase 970,000 shares during the period from August through December 2008, pursuant to the terms of their compensation arrangements. The exercise prices range from $0.42 to $0.72, and the options expire 3 years following the date of issuance.
ITEM 3. | DEFAULTS UPON SENIOR SECURITIES |
None
ITEM 4. | SUBMISSION OF MATTERS TO A VOTE AMONG SECURITY HOLDERS |
None
ITEM 5. | OTHER INFORMATION |
On September 22, 2008, we entered into a license agreement with Glucometrics, Inc., an unrelated third party, pursuant to which we licensed the intellectual property pertaining to our implanted glucose biosensor to monitor blood glucose for the development, manufacture, and marketing of products that use or incorporate the intellectual property. In exchange for the license we acquired:
| a 10% equity interest in Glucometrics; |
| the right to receive a royalty payment on implantable products equal to 10% of the first $10 million in net sales, 8% of the next $40 million of net sales, and 6% of net sales equal to or greater than $50 million; |
| the right to receive a royalty payment on non-implantable products equal to 8% of the first $5 million in net sales, 6% of the next $20 million of net sales, and 4% of net sales equal to or greater than $25 million; and |
| participation in fees and payments made under sublicensing arrangements. |
The term of the license agreement is for the life of the patent right licensed under the agreement.
ITEM 6. | EXHIBITS. |
(a) | Exhibits: |
31.1 | Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2 | Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1 | Certification Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
OXYGEN BIOTHERAPEUTICS INTERNATIONAL, INC. | ||||
December 22, 2008 | /s/ Chris J. Stern | |||
Chris J. Stern, Chief Executive Officer | ||||
(Principal Executive Officer) | ||||
December 22 ,2008 | /s/ Charles H. Seeman | |||
Charles H. Seeman, Chief Financial Officer | ||||
(Principal Financial Officer and Principal | ||||
Accounting Officer) |
18