Business Context and Reporting Period
Company: Oxygen Biotherapeutics, Inc. (formerly Synthetic Blood International, Inc.)
Filing Type: Form 10-Q (Quarterly Report)
Period Ended: October 31, 2008
Status: Development Stage Company / Smaller Reporting Company
The Company is a biotechnology firm developing medical products based on perfluorocarbon technology, primarily focusing on Oxycyte (a synthetic oxygen carrier) and topical wound healing therapies. The Company has no product revenue and relies entirely on external financing. On June 30, 2008, the Company completed a merger to change its domicile from New Jersey to Delaware.
Key Financial Metrics
| Metric | Six Months Ended Oct 31, 2008 | Six Months Ended Oct 31, 2007 |
|---|---|---|
| Revenue | $0 | $0 |
| Net Loss | $(8,160,293) | $(1,959,166) |
| Net Loss Per Share (Basic & Diluted) | $(0.0372) | $(0.005) |
| Cash and Cash Equivalents (Oct 31, 2008) | $5,204,555 | $731 (Oct 31, 2007) |
| Working Capital | $5,120,669 | Filing text does not provide clear value for 2007 |
| Long-Term Debt (Convertible Notes, net) | $1,643,992 | $539,786 (April 30, 2008) |
| Accumulated Deficit | $(45,901,655) | $(37,741,362) (April 30, 2008) |
Cash Flow Summary (Six Months Ended Oct 31, 2008):
- Net cash used in operating activities: $(2,518,373)
- Net cash used in investing activities: $(93,659)
- Net cash provided by financing activities: $2,181,993
Material Changes vs. Prior Period
- Increased Operating Losses: Net loss increased significantly from $1.96 million to $8.16 million for the six-month period. This was driven by a surge in General and Administrative (G&A) expenses and Interest Expense.
- G&A Expense Spike: G&A expenses rose from $392,114 to $4,939,163. Approximately $2.29 million of this increase was due to specialized management consultants, and $1.53 million was attributed to stock-based compensation costs.
- Interest Expense: Interest expense increased by approximately $1.49 million to $2.82 million, largely due to the issuance of convertible notes with significant original issue discounts and beneficial conversion features in the prior fiscal year.
- Financing Activity: The Company raised significant capital through the sale of convertible notes and the exercise of warrants, resulting in a cash balance increase from $4.88 million (April 30, 2008) to $5.20 million (October 31, 2008).
- Asset Restructuring: The Company assigned glucose monitoring patent rights to Glucometrics, Inc. in exchange for a 10% equity interest and royalty rights, recognizing a gain of $26,622.
Guidance, Outlook, Risks, and Unusual Items
Outlook and Guidance
Management expects to require substantial additional funds to complete clinical trials and pursue regulatory approvals. While the Company believes it has sufficient working capital to fund operations through fiscal year 2009, it anticipates needing additional financing by July 31, 2009, or the end of 2009. There is no assurance that funding will be available.
Management Commentary
- Oxycyte Development: Phase II-A trials for traumatic brain injury (TBI) were completed with good results. The Company is revising the Phase II-B protocol following an October 2008 meeting with the FDA, which requested additional data on side effects (thrombocytopenia). The revised protocol is expected to be filed in Q1 2009.
- New Therapies: The Company is increasing focus on topical wound healing therapies using perfluorocarbon technology, having licensed relevant patents from Virginia Commonwealth University (VCU) in May 2008.
Risks and Contingencies
- Going Concern: The Company has an accumulated deficit of $45.9 million and continues to sustain operating losses. Substantial doubt exists regarding its ability to continue as a going concern without additional financing.
- Registration Requirements: The Company has withdrawn a registration statement required for certain convertible notes and warrants. Failure to resolve this by January 9, 2009, could trigger liquidated damages of 1% of the aggregate market value of the stock.
- Internal Controls: Management concluded that disclosure controls and procedures were not effective as of October 31, 2008, due to material weaknesses including incompatible duties in cash disbursement and insufficient accounting personnel.
Unusual Items
- Warrant Pricing Error: The Company returned $140,000 to investors due to pricing errors in warrant exercises and expensed $12,500 as a bad debt related to a similar error.
- Debt Extinguishment: A loss of $250,097 was recorded upon exchanging short-term loans for five-year convertible notes.
Investor Verification Checklist
- Financing Runway: Verify the timeline for securing additional equity or debt financing, as management projects a funding gap by mid-to-late 2009.
- Registration Statement Status: Confirm the resolution of the withdrawn registration statement to avoid potential 1% liquidated damages on outstanding warrants and notes.
- Internal Control Remediation: Monitor progress on hiring administrative staff and implementing segregation of duties to address material weaknesses in financial reporting.
- FDA Protocol Approval: Track the submission and approval status of the revised Phase II-B protocol for Oxycyte in TBI patients.
- Dilution Risk: Assess the impact of outstanding warrants (121 million) and convertible notes (face value ~$20 million) on future share count and earnings per share.