SAFESTITCH MEDICAL, INC. |
(Exact name of registrant as specified in its charter) |
| Delaware | | 11-2962080 | |
| (State or other jurisdiction of incorporation or organization) | | (I.R.S. employer identification no.) | |
| 4400 Biscayne Blvd., Suite A-100, Miami, Florida | | 33137 | |
| (Address of principal executive offices) | | (Zip code) | |
Large accelerated filer ¨ | Accelerated filer ¨ | Non-accelerated filer ¨ | Smaller reporting company x |
PART I. FINANCIAL INFORMATION | | |
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ITEM 1. | FINANCIAL STATEMENTS | 3 |
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| Condensed Consolidated Balance Sheets as of June 30, 2013 (unaudited) and December 31, 2012 | 3 |
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| Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income for the Three and Six Months ended June 30, 2013 and 2012, and for the period from September 15, 2005 (inception) to June 30, 2013 | 4 |
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| Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the period from September 15, 2005 (inception) through June 30, 2013 (unaudited) | 5 |
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| Unaudited Condensed Consolidated Statements of Cash Flows for the Six Months ended June 30, 2013 and 2012, and for the period from September 15, 2005 (inception) to June 30, 2013 | 6 |
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| Notes to unaudited condensed consolidated financial statements | 7 |
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ITEM 2. | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 16 |
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ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 19 |
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ITEM 4. | CONTROLS AND PROCEDURES | 19 |
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PART II. OTHER INFORMATION | | |
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ITEM 1. | LEGAL PROCEEDINGS | 20 |
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ITEM 1A . | RISK FACTORS | 20 |
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ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS | 20 |
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ITEM 3. | DEFAULTS UPON SENIOR SECURITIES | 20 |
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ITEM 4. | MINE SAFETY DISCLOSURE | 20 |
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ITEM 5. | OTHER INFORMATION | 20 |
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ITEM 6. | EXHIBITS | 20 |
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| SIGNATURES | 21 |
| | June 30, | | December 31, | | ||
| | 2013 | | 2012 | | ||
| | (Unaudited) | | | | | |
ASSETS | | | | | | | |
CURRENT ASSETS | | | | | | | |
Cash and cash equivalents | | $ | 1,026 | | $ | 275 | |
Accounts Receivable trade | | | 5 | | | 12 | |
Other receivable related-party | | | 63 | | | 59 | |
Prepaid expenses | | | 72 | | | 140 | |
Inventories | | | 1,482 | | | 1,600 | |
Total Current Assets | | | 2,648 | | | 2,086 | |
FIXED ASSETS | | | | | | | |
Property and equipment, net | | | 264 | | | 332 | |
OTHER ASSETS | | | | | | | |
Security deposits | | | 2 | | | 2 | |
Total Other Assets | | | 2 | | | 2 | |
TOTAL ASSETS | | $ | 2,914 | | $ | 2,420 | |
| | | | | | | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | | | | |
CURRENT LIABILITIES | | | | | | | |
Accounts payable and accrued liabilities | | $ | 615 | | $ | 1,224 | |
Accounts payable and accrued liabilities related party | | | 52 | | | 39 | |
Stockholder loans, including accrued interest ( Note 5) | | | | | | 912 | |
Total Current Liabilities | | | 667 | | | 2,175 | |
Commitments and contingencies (Note 8) | | | | | | | |
STOCKHOLDERS’ EQUITY | | | | | | | |
Common stock, $0.001 par value per share, 225,000,000 shares authorized, 61,699,276 and 49,603,276 shares issued and outstanding | | | 62 | | | 50 | |
Additional paid-in capital | | | 33,223 | | | 29,708 | |
Deficit accumulated during the development stage | | | (31,038) | | | (29,513) | |
Total Stockholders’ Equity | | | 2,247 | | | 245 | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | | $ | 2,914 | | $ | 2,420 | |
| | Three Months Ended June 30, | | Six Months Ended June 30, | | | September 15, 2005 (Inception) to June 30, | | ||||||||
| | 2013 | | 2012 | | 2013 | | 2012 | | 2013 | | |||||
| | | | | | | | | | | | | | | | |
Revenues | | $ | 6 | | $ | 9 | | $ | 17 | | $ | 9 | | $ | 52 | |
Cost of sales | | | 3 | | | 171 | | | 7 | | | 171 | | | 389 | |
Gross margin | | | 3 | | | (162) | | | 10 | | | (162) | | | (337) | |
| | | | | | | | | | | | | | | | |
Operating costs and expenses | | | | | | | | | | | | | | | | |
Research and development | | | 372 | | | 769 | | | 520 | | | 1,947 | | | 16,374 | |
Selling, general and administrative | | | 591 | | | 1,068 | | | 992 | | | 1,981 | | | 13,379 | |
Total operating costs and expenses | | | 963 | | | 1,837 | | | 1,512 | | | 3,928 | | | 29,753 | |
| | | | | | | | | | | | | | | | |
Operating loss | | | (960) | | | (1,999) | | | (1,502) | | | (4,090) | | | (30,090) | |
| | | | | | | | | | | | | | | | |
Other income and expense | | | | | | | | | | | | | | | | |
Other income | | | | | | | | | | | | | | | 1,147 | |
| | | | | | | | | | | | | | | | |
Interest income, net | | | | | | | | | | | | | | | 79 | |
| | | | | | | | | | | | | | | | |
Amortization of deferred financing cost | | | | | | (3) | | | | | | (5) | | | (1,984) | |
| | | | | | | | | | | | | | | | |
Interest exp | | | | | | | | | (23) | | | (43) | | | (190) | |
Total other income and expense | | | | | | (3) | | | (23) | | | (48) | | | (948) | |
Loss before provision for income tax | | | (960) | | | (2,002) | | | (1,525) | | | (4,138) | | | (31,038) | |
Provision for income tax | | | | | | | | | | | | | | | | |
Net loss | | $ | (960) | | $ | (2,002) | | $ | (1,525) | | $ | (4,138) | | $ | (31,038) | |
Comprehensive income (loss) | | $ | 0 | | $ | 0 | | $ | 0 | | $ | 0 | | $ | 0 | |
Comprehensive loss | | $ | (960) | | $ | (2,002) | | $ | (1,525) | | $ | (4,138) | | $ | (31,038) | |
| | | | | | | | | | | | | | | | |
Loss attributable to common stockholders and loss per common share: | | | | | | | | | | | | | | | | |
Net loss | | | (960) | | | (2,002) | | | (1,525) | | | (4,138) | | | (31,038) | |
Deemed dividend - Series A Preferred Stock | | | | | | | | | | | | | | | (700) | |
Deemed dividend Series A Preferred | | | | | | | | | | | | | | | | |
Conversion | | | | | | | | | | | | | | | (4,301) | |
Dividends - Series A Preferred Stock | | | | | | | | | | | | | | | (366) | |
| | | | | | | | | | | | | | | | |
Net loss attributable to common stockholders | | $ | (960) | | $ | (2,002) | | $ | (1,525) | | $ | (4,138) | | $ | (36,405) | |
| | | | | | | | | | | | | | | | |
Weighted average shares outstanding, basic and diluted | | | 61,699 | | | 48,798 | | | 56,286 | | | 43,314 | | | | |
| | | | | | | | | | | | | | | | |
Net loss per basic and diluted share | | $ | (0.02) | | $ | (0.04) | | $ | (0.03) | | $ | (0.10) | | | | |
| | | | | | | | | | | | | | Additional | | Deficit Accumulated During the | | | | | ||
| | Preferred Stock | | Common Stock | | Paid-in | | Development | | | | | ||||||||||
| | Shares | | Amount | | Shares | | Amount | | Capital | | Stage | | Total | | |||||||
| | | | | | | | | | | | | | | | | | | | | | |
Inception September 15, 2005 | | | | | $ | | | | | | $ | | | $ | | | $ | | | $ | | |
| | | | | | | | | | | | | | | | | | | | | | |
Capital contributed | | | | | | | | | | | | | | | 1 | | | | | | 1 | |
Net loss | | | | | | | | | | | | | | | | | | (76) | | | (76) | |
Balance at December 31, 2005 | | | | | $ | | | | | | $ | | | $ | 1 | | $ | (76) | | $ | (75) | |
| | | | | | | | | | | | | | | | | | | | | | |
Capital contributed | | | | | | | | | 11,256 | | | 11 | | | 1,493 | | | | | | 1,504 | |
Net loss | | | | | | | | | | | | | | | | | | (1,060) | | | (1,060) | |
Balance at December 31, 2006 | | | | | $ | | | | 11,256 | | $ | 11 | | $ | 1,494 | | $ | (1,136) | | $ | 369 | |
| | | | | | | | | | | | | | | | | | | | | | |
Capital contributed | | | | | | | | | 4,837 | | | 5 | | | 5,088 | | | | | | 5,093 | |
Net loss | | | | | | | | | | | | | | | | | | (3,041) | | | (3,041) | |
Balance at December 31, 2007 | | | | | $ | | | | 16,093 | | $ | 16 | | $ | 6,582 | | $ | (4,177) | | $ | 2,421 | |
| | | | | | | | | | | | | | | | | | | | | | |
Issuance of common shares in private offering May 2008 at $2.15 per share, net of offering costs | | | | | | | | | 1,862 | | | 2 | | | 3,986 | | | | | | 3,988 | |
Issuance of common shares as repayment of stockholder note-December 30, 2008 at $1.22 per share | | | | | | | | | 8 | | | | | | 10 | | | | | | 10 | |
Stock-based compensation | | | | | | | | | | | | | | | 239 | | | | | | 239 | |
Net loss | | | | | | | | | | | | | | | | | | (5,185) | | | (5,185) | |
Balance at December 31, 2008 | | | | | $ | | | | 17,963 | | $ | 18 | | $ | 10,817 | | $ | (9,362) | | $ | 1,473 | |
| | | | | | | | | | | | | | | | | | | | | | |
Issuance of Series A Preferred Stock in July 2009 at $1.00 per share | | | 2,000 | | | 20 | | | | | | | | | 1,962 | | | | | | 1,982 | |
Fair value of beneficial conversion feature of Series A Preferred Stock | | | | | | | | | | | | | | | 200 | | | | | | 200 | |
Deemed dividend to Series A Preferred Stockholders, charged to additional paid-in capital in the absence of retained earnings | | | | | | | | | | | | | | | (200) | | | | | | (200) | |
Stock-based compensation | | | | | | | | | | | | | | | 195 | | | | | | 195 | |
Net loss | | | | | | | | | | | | | | | | | | (2,366) | | | (2,366) | |
Balance at December 31, 2009 | | | 2,000 | | $ | 20 | | | 17,963 | | $ | 18 | | $ | 12,974 | | $ | (11,728) | | $ | 1,284 | |
| | | | | | | | | | | | | | | | | | | | | | |
Issuance of Series A Preferred Stock in January 2010 at $1.00 per share | | | 2,000 | | | 20 | | | | | | | | | 1,978 | | | | | | 1,998 | |
Fair value of beneficial conversion feature of Series A Preferred Stock | | | | | | | | | | | | | | | 500 | | | | | | 500 | |
Deemed dividend to Series A Preferred Stockholders, charged to additional paid-in capital in the absence of retained earnings | | | | | | | | | | | | | | | (500) | | | | | | (500) | |
Issuance of common shares in private offering - June 2010 at $1.00 per share, net of offering costs | | | | | | | | | 4,978 | | | 5 | | | 4,969 | | | | | | 4,974 | |
Conversion of 4,000 shares of Series A Preferred Stock and accumulated dividends into 4,366 shares of Common Stock in September 2010 | | | (4,000) | | | (40) | | | 4,366 | | | 4 | | | 36 | | | | | | | |
Issuance of 697 shares of Common Stock as Consideration Shares in September 2010 | | | | | | | | | 697 | | | 1 | | | (1) | | | | | | | |
Intrinsic value of 5,063 aggregate shares of Common Stock issued on conversion of Series A Preferred Stock | | | | | | | | | | | | | | | 4,301 | | | | | | 4,301 | |
Dividend paid to Series A Preferred Stockholders on conversion, charged to additional paid-in capital in the absence of retained earnings | | | | | | | | | | | | | | | (4,301) | | | | | | (4,301) | |
Stock-based compensation | | | | | | | | | | | | | | | 471 | | | | | | 471 | |
Net loss | | | | | | | | | | | | | | | | | | (5,303) | | | (5,303) | |
Balance at December 31, 2010 | | | | | $ | | | | 28,004 | | $ | 28 | | $ | 20,427 | | $ | (17,031) | | $ | 3,424 | |
Stock-based compensation | | | | | | | | | | | | | | | 335 | | | | | | 335 | |
Net loss | | | | | | | | | | | | | | | | | | (5,758) | | | (5,758) | |
Balance at December 31, 2011 | | | | | $ | | | | 28,004 | | $ | 28 | | $ | 20,762 | | $ | (22,789) | | $ | (1,999) | |
| | | | | | | | | | | | | | | | | | | | | | |
Issuance of 20,794,000 shares of Common Stock at $0.40 per share for cash in February 2012 | | | | | | | | | 20,794 | | | 21 | | | 8,297 | | | | | | 8,318 | |
Issuance of 805,521 shares of Common Stock for Warrants as $0.25 per share for cash in October 2012 | | | | | | | | | 805 | | | 1 | | | 200 | | | | | | 201 | |
Stock-based compensation | | | | | | | | | | | | | | | 448 | | | | | | 448 | |
Net loss | | | | | | | | | | | | | | | | | | (6,274) | | | (6,724) | |
Balance at December 31, 2012 | | | | | $ | | | | 49,603 | | $ | 50 | | $ | 29,708 | | $ | (29,513) | | $ | 245 | |
Issuance of 12,096,000 shares of Common Stock at $0.25 per share for cash in March 2013 | | | | | | | | | 12,096 | | | 12 | | | 3,012 | | | | | | 3,024 | |
Stock-based compensation | | | | | | | | | | | | | | | 503 | | | | | | 503 | |
Net loss | | | | | | | | | | | | | | | | | | (1,525) | | | (1,525) | |
Balance at June 30, 2013 (unaudited) | | | | | $ | | | | 61,699 | | $ | 62 | | $ | 33,223 | | $ | (31,038) | | $ | 2,247 | |
| | Six Months Ended June 30, | | September 15, 2005 (Inception) to June 30, | | |||||
| | 2013 | | 2012 | | 2013 | | |||
OPERATING ACTIVITIES | | | | | | | | | | |
Net loss | | $ | (1,525) | | $ | (4,138) | | $ | (31,038) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | | | | | |
Amortization of deferred finance costs | | | | | | 5 | | | 1,984 | |
Stock-based compensation expense | | | 503 | | | 224 | | | 2,256 | |
Stock-based compensation expense related to Share Exchange | | | | | | | | | 77 | |
Depreciation and amortization | | | 68 | | | 84 | | | 577 | |
Loss from disposal of assets | | | | | | | | | 20 | |
Inventory Adjustments | | | | | | | | | 337 | |
Gain on sale of TruePosition investment | | | | | | | | | (903) | |
Changes in operating assets and liabilities | | | | | | | | | | |
Inventories | | | 14 | | | (1,646) | | | (1,923) | |
Accounts receivable | | | 3 | | | | | | 3 | |
Other current assets | | | 68 | | | 8 | | | (120) | |
Other assets | | | | | | | | | (2) | |
Accounts payable and accrued liabilities | | | (492) | | | 677 | | | 487 | |
Accrued Interest | | | (12) | | | (48) | | | | |
NET CASH USED IN OPERATING ACTIVITIES | | | (1,373) | | | (4,834) | | | (28,248) | |
| | | | | | | | | | |
INVESTING ACTIVITIES | | | | | | | | | | |
Purchase of equipment | | | | | | (6) | | | (861) | |
Proceeds from sale of True Position investment | | | | | | | | | 903 | |
Payment received under Rule 16b | | | | | | | | | 4 | |
NET CASH (USED IN) PROVIDED BY INVESTING ACTIVITIES | | | | | | (6) | | | 46 | |
| | | | | | | | | | |
FINANCING ACTIVITIES | | | | | | | | | | |
Net cash provided in connection with the acquisition of SafeStitch LLC | | | | | | | | | 3,192 | |
Issuance of Common Stock, net of offering costs | | | 3,024 | | | 8,318 | | | 20,305 | |
Issuance of Preferred Stock, net of offering costs | | | | | | | | | 3,980 | |
Capital contributions | | | | | | | | | 1,431 | |
Proceeds from notes payable | | | | | | | | | 141 | |
Repayment of notes payable | | | | | | | | | (141) | |
Proceeds from stockholder loans | | | 200 | | | 500 | | | 6,935 | |
Repayment of stockholder loans | | | (1,100) | | | (2,975) | | | (6,851) | |
Exercise of warrants | | | | | | | | | 201 | |
Exercise of options | | | | | | | | | 35 | |
NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES | | | 2,124 | | | 5,843 | | | 29,228 | |
| | | | | | | | | | |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | | | 751 | | | 1,003 | | | 1,026 | |
| | | | | | | | | | |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | | | 275 | | | 298 | | | | |
| | | | | | | | | | |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | | $ | 1,026 | | $ | 1,301 | | $ | 1,026 | |
| | | | | | | | | | |
Supplemental disclosures: | | | | | | | | | | |
Cash paid for interest | | $ | 35 | | $ | 91 | | $ | 191 | |
Non cash activities: | | | | | | | | | | |
Non-cash inventory and accounts payable adjustment | | $ | 104 | | $ | | | $ | 104 | |
Non-cash dividend upon issuance & conversion of Preferred | | $ | | | $ | | | $ | 5,001 | |
Stock dividends | | $ | | | $ | | | $ | 366 | |
Stockholder loans contributed to capital | | $ | | | $ | | | $ | 84 | |
Warrants issued in connection with credit facility | | $ | | | $ | | | $ | 1,985 | |
⋅ | Level 1 - Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. | |
⋅ | Level 2 - Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. | |
⋅ | Level 3 - Inputs that are both significant to the fair value measurement and unobservable. |
| | Estimated Useful Lives | | June 30, 2013 | | December 31, 2012 | | ||
Machinery and equipment | | 5 years | | $ | 682,000 | | $ | 682,000 | |
Furniture, fixtures and leasehold improvements | | 3-5 years | | | 88,000 | | | 88,000 | |
Software | | 3-5 years | | | 57,000 | | | 57,000 | |
| | | | | 827,000 | | | 827,000 | |
Accumulated depreciation and amortization | | | | | (563,000) | | | (495,000) | |
Property and equipment, net | | | | $ | 264,000 | | $ | 332,000 | |
| | Six months ended June 30, 2013 | | Six months ended June 30, 2012 |
Expected volatility | | 98% - 136% | | 85.41% - 111.36% |
Expected dividend yield | | 0.00% | | 0.00% |
Risk-free interest rate | | 0.92% 1.71% | | 1.02% 1.98% |
Expected life | | 5.5 10.0 years | | 5.5 10.0 years |
Forfeiture rate | | 0% - 2% | | 0% - 2% |
| Shares | | Weighted Average Exercise Price | | Weighted Average Remaining Contractual Term (Years) | | Aggregate Intrinsic Value | ||
Outstanding at December 31, 2012 | 2,079,000 | | $ | 1.03 | | 6.77 | | | |
Granted | 1,693,500 | | $ | 0.45 | | 9.82 | | | |
Exercised | | | | | | | | | |
Canceled or expired | (225,500) | | $ | 1.14 | | | | | |
Outstanding at June 30, 2013 | 3,547,000 | | $ | 0.75 | | 7.94 | | $ | 0 |
Exercisable at June 30, 2013 | 2,429,875 | | $ | 0.82 | | 7.37 | | $ | 0 |
Vested and expected to vest at June 30, 2013 | 3,520,218 | | $ | 0.75 | | 7.90 | | $ | 0 |
| | June 30, 2013 | | June 30, 2012 | | ||
Stock options | | | 3,547,000 | | | 2,344,500 | |
Stock warrants | | | 6,050,000 | | | 805,521 | |
Total | | | 9,597,000 | | | 3,150,021 | |
| | | Exhibits: |
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| 31.1 | | Certification of Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14(a) |
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| 31.2 | | Certification of Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14(a) |
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| 32.1 | | Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002* |
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| 32.2 | | Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002* |
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| 101.INS | | XBRL Instance Document** |
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| 101.SCH | | XBRL Taxonomy Extension Schema Document** |
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| 101.CAL | | XBRL Taxonomy Extension Calculation Linkbase Document** |
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| 101.DEF | | XBRL Taxonomy Extension Definition Linkbase Document** |
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| 101.LAB | | XBRL Taxonomy Extension Label Linkbase Document** |
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| 101.PRE | | XBRL Taxonomy Extension Presentation Linkbase Document** |
* | Pursuant to Item 601(b)(32) of Regulation S-K, this exhibit is furnished, rather than filed, with this Quarterly Report on Form 10-Q. |
| |
** | Pursuant to Rule 406T of Regulation S-T, these interactive data files are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933 or Section 18 of the Securities Act of 1934 and otherwise not subject to liability. |
SAFESTITCH MEDICAL, INC. | ||
Date: August 14, 2013 | By: | /s/ Jeffrey G. Spragens |
| Jeffrey G. Spragens | |
| President and Chief Executive Officer | |
Date: August 14, 2013 | By: | /s/ James J. Martin |
| James J. Martin | |
| Chief Financial Officer |
1. | I have reviewed this Quarterly Report on Form 10-Q of SafeStitch Medical, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c. | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d. | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| By: | /s/ Jeffrey G. Spragens | |
| Jeffrey G. Spragens | | |
| Chief Executive Officer (Principal Executive Officer) | | |
| August 14, 2013 | |
1. | I have reviewed this Quarterly Report on Form 10-Q of SafeStitch Medical, Inc.; |
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
4. | The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c. | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d. | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. | The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| By: | /s/ James J. Martin | |
| James J. Martin | | |
| Chief Financial Officer | | |
| August 14, 2013 | |
(1) | the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
| |
(2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
| By: | /s/ Jeffrey G. Spragens |
| Jeffrey G. Spragens | |
| Chief Executive Officer and President | |
| August 14, 2013 |
(1) | the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
| By: | /s/ James J. Martin | |
| James J. Martin | ||
| Chief Financial Officer | ||
| August 14, 2013 |
INCOME TAXES
|
6 Months Ended |
---|---|
Jun. 30, 2013
|
|
Income Taxes [Abstract] | |
INCOME TAXES | NOTE 10 INCOME TAXES The Company accounts for income taxes using the asset and liability method, the objective of which is to establish deferred tax assets and liabilities for the temporary differences between the financial reporting and the tax bases of the Company’s assets and liabilities at enacted tax rates expected to be in effect when such amounts are realized or settled. A valuation allowance related to deferred tax assets is recorded when it is more likely than not that some portion or all of the deferred tax assets will not be realized. All of the Company’s deferred tax assets have been fully reserved by a valuation allowance due to management's uncertainty regarding the future profitability of the Company. The Company has recognized no adjustment for uncertain tax provisions. SafeStitch recognizes interest and penalties related to uncertain tax positions in selling, general and administrative costs and expenses; however no such provisions for accrued interest and penalties related to uncertain tax positions have been recorded as of June 30, 2013 or December 31, 2012. The tax years 2009-2012 remain open to examination by the major tax jurisdictions in which the Company operates. |
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (USD $)
In Thousands, except Share data, unless otherwise specified |
3 Months Ended | 6 Months Ended | 93 Months Ended | ||
---|---|---|---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jun. 30, 2013
|
|
Revenues | $ 6 | $ 9 | $ 17 | $ 9 | $ 52 |
Cost of sales | 3 | 171 | 7 | 171 | 389 |
Gross margin | 3 | (162) | 10 | (162) | (337) |
Operating costs and expenses | |||||
Research and development | 372 | 769 | 520 | 1,947 | 16,374 |
Selling, general and administrative | 591 | 1,068 | 992 | 1,981 | 13,379 |
Total operating costs and expenses | 963 | 1,837 | 1,512 | 3,928 | 29,753 |
Operating loss | (960) | (1,999) | (1,502) | (4,090) | (30,090) |
Other income and expense | |||||
Other income | 0 | 0 | 0 | 0 | 1,147 |
Interest income, net | 0 | 0 | 0 | 0 | 79 |
Amortization of deferred financing cost | 0 | (3) | 0 | (5) | (1,984) |
Interest exp | 0 | 0 | (23) | (43) | (190) |
Total other income and expense | 0 | (3) | (23) | (48) | (948) |
Loss before provision for income tax | (960) | (2,002) | (1,525) | (4,138) | (31,038) |
Provision for income tax | 0 | 0 | 0 | 0 | 0 |
Net loss | (960) | (2,002) | (1,525) | (4,138) | (31,038) |
Comprehensive income (loss) | 0 | 0 | 0 | 0 | 0 |
Comprehensive loss | (960) | (2,002) | (1,525) | (4,138) | (31,038) |
Loss attributable to common stockholders and loss per common share: | |||||
Net loss | (960) | (2,002) | (1,525) | (4,138) | (31,038) |
Net loss attributable to common stockholders | (960) | (2,002) | (1,525) | (4,138) | (36,405) |
Weighted average shares outstanding, basic and diluted (in shares) | 61,699 | 48,798 | 56,286 | 43,314 | |
Net loss per basic and diluted share (in dollars per share) | $ (0.02) | $ (0.04) | $ (0.03) | $ (0.10) | |
Series A Preferred Conversion
|
|||||
Loss attributable to common stockholders and loss per common share: | |||||
Deemed dividend | 0 | 0 | 0 | 0 | (4,301) |
Series A Preferred Stock
|
|||||
Loss attributable to common stockholders and loss per common share: | |||||
Deemed dividend | 0 | 0 | 0 | 0 | (700) |
Dividends - Series A Preferred Stock | $ 0 | $ 0 | $ 0 | $ 0 | $ (366) |
PROPERTY AND EQUIPMENT
|
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2013
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Property and Equipment [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
PROPERTY AND EQUIPMENT | NOTE 3 PROPERTY AND EQUIPMENT Property and equipment consist of the following:
Depreciation of fixed assets utilized in research and development activities is included in research and development costs and expenses. All other depreciation is included in selling, general and administrative costs and expenses. Depreciation and amortization expense was $33,000 and $68,000, respectively for the three and six months ended June 30, 2013, and was $42,000 and $84,000, respectively for the three and six months ended June 30, 2012. |
BASIC AND DILUTED NET LOSS PER SHARE (TABLES)
|
6 Months Ended | |||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2013
|
||||||||||||||||||||||||||||||||||
Basic and Diluted Net Loss Per Share [Abstract] | ||||||||||||||||||||||||||||||||||
Summary of Potential Common Shares | Potential common shares not included in calculating diluted net loss per share are as follows:
|
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS
|
6 Months Ended |
---|---|
Jun. 30, 2013
|
|
Certain Relationships and Related Party Transactions [Abstract] | |
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS | NOTE 11 CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS As more fully described in Note 5, the Company entered into a $4.0 million Credit Facility with Jeffrey G. Spragens, the Company’s President, Chief Executive Officer and director, and The Frost Group. The Company entered into a five-year lease for office space in Miami, Florida with a company controlled by Dr. Frost. The non-cancelable lease, which commenced January 1, 2008, provides for a 4.5% annual rent increase over the life of the lease. The Miami office lease was amended in August 2011 to include additional office space in the same building, and current rental payments under the lease are approximately $16,000 per month. The Company recorded rent expense related to the Miami lease totaling approximately $48,000 and $99,000, respectively, for the three and six months ended June 30, 2013, and $69,000 and $126,000, respectively, for the three and six months ended June 30, 2012. Dr. Hsiao, Dr. Frost and director Steven Rubin are each significant stockholders and/or directors of Non-Invasive Monitoring Systems, Inc. (“NIMS”), a publicly-traded medical device company, Aero Pharmaceuticals, Inc. (“Aero”), a privately-held pharmaceutical distribution company that dissolved in December 2011, Tiger X Medical, Inc. (“Tiger X”) (formerly known as Cardo Medical, Inc.), a publicly-traded medical device company, and TigerMedia, Inc. (“TigerMedia) (formerly known as SearchMedia Holdings Limited), a publicly-traded media company operating primarily in China. Director Richard Pfenniger is also a shareholder of NIMS. The Company’s Chief Financial Officer also serves as the Chief Financial Officer and supervises the accounting staffs of NIMS and, until its dissolution, Aero, under a Board-approved cost sharing arrangement whereby the total salaries of the accounting staffs of the three companies are shared. Aero has not participated in the cost sharing arrangement since June 30, 2011 and was dissolved in December 2011. Since December 2009, the Company’s Chief Legal Officer has served under a similar Board-approved cost sharing arrangement as Corporate Counsel of TigerMedia and as the Chief Legal Officer of each of NIMS and Tiger X. The Company has recorded reductions to selling, general and administrative costs and expenses to account for the sharing of costs under these arrangements of $50,000 and $100,000, respectively, for the three and six months ended June 30, 2013, and $52,000 and $103,000, respectively, for the three and six months ended June 30, 2012. Aggregate accounts receivable from NIMS, Tiger X and TigerMedia were approximately $63,000 and $59,000 as of June 30, 2013 and December 31, 2012, respectively and are included in other receivablerelated party. |
INCOME TAXES (Details Textual)
|
6 Months Ended |
---|---|
Jun. 30, 2013
|
|
Maximum [Member]
|
|
Income Taxes (Textual) [Abstract] | |
Tax years open to examination by major tax jurisdictions | 2012 |
Minimum [Member]
|
|
Income Taxes (Textual) [Abstract] | |
Tax years open to examination by major tax jurisdictions | 2009 |
PROPERTY AND EQUIPMENT (Details) (USD $)
|
6 Months Ended | |
---|---|---|
Jun. 30, 2013
|
Dec. 31, 2012
|
|
Summary of Property and equipment | ||
Property and equipment, Gross | $ 827,000 | $ 827,000 |
Accumulated depreciation and amortization | (563,000) | (495,000) |
Property and equipment, net | 264,000 | 332,000 |
Machinery and Equipment [Member]
|
||
Summary of Property and equipment | ||
Estimated Useful Lives | 5 years | |
Property and equipment, Gross | 682,000 | 682,000 |
Furniture, Fixtures and Leasehold Improvements [Member]
|
||
Summary of Property and equipment | ||
Property and equipment, Gross | 88,000 | 88,000 |
Furniture, Fixtures and Leasehold Improvements [Member] | Maximum [Member]
|
||
Summary of Property and equipment | ||
Estimated Useful Lives | 5 years | |
Furniture, Fixtures and Leasehold Improvements [Member] | Minimum [Member]
|
||
Summary of Property and equipment | ||
Estimated Useful Lives | 3 years | |
Software [Member]
|
||
Summary of Property and equipment | ||
Property and equipment, Gross | $ 57,000 | $ 57,000 |
Software [Member] | Maximum [Member]
|
||
Summary of Property and equipment | ||
Estimated Useful Lives | 5 years | |
Software [Member] | Minimum [Member]
|
||
Summary of Property and equipment | ||
Estimated Useful Lives | 3 years |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Textual) (USD $)
|
3 Months Ended | 6 Months Ended | |||
---|---|---|---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jun. 30, 2013
|
Jun. 30, 2012
|
Dec. 31, 2012
|
|
Summary of Significant Accounting Policies (Textual) [Abstract] | |||||
Number Of AMID HFD units in inventory | 5,800 | ||||
Marketing and Advertising Expense | $ 0 | $ 45,000 | $ 520 | $ 83,000 | |
AMID HFD [Member]
|
|||||
Summary of Significant Accounting Policies (Textual) [Abstract] | |||||
Number Of AMID HFD units in inventory | 5,707 | 5,707 | |||
Number Of Units In Revenue | 26 | 24 | 62 | 24 | |
Number Of Units In Revenue For Demonstration | 42 | 516 | 60 | 516 |
BASIC AND DILUTED NET LOSS PER SHARE (Details)
|
6 Months Ended | |
---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
|
Summary of Potential Common Shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | 9,597,000 | 3,150,021 |
Employee Stock Option [Member]
|
||
Summary of Potential Common Shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | 3,547,000 | 2,344,500 |
Stock Warrants [Member]
|
||
Summary of Potential Common Shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | 6,050,000 | 805,521 |
EMPLOYEE BENEFIT PLANS (Details Textual) (USD $)
|
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2013
|
Jun. 30, 2012
|
Jun. 30, 2013
|
Jun. 30, 2012
|
|
Employee Benefit Plans (Textual) [Abstract] | ||||
Employee contribution to annual compensation | 100.00% | 100.00% | ||
Employer contribution matching plan | 100.00% | 100.00% | ||
Percentage of participant's qualified annual earnings | 4.00% | 4.00% | ||
Expenses recorded related to plan | $ 8,000 | $ 4,000 | $ 13,000 | $ 15,000 |
BASIS OF PRESENTATION AND LIQUIDITY (Details Textual) (USD $)
|
1 Months Ended | 12 Months Ended | 1 Months Ended | 6 Months Ended | 1 Months Ended | 12 Months Ended | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Feb. 29, 2012
|
Dec. 31, 2010
|
Dec. 31, 2008
|
Jun. 30, 2013
|
Dec. 31, 2012
|
Sep. 16, 2005
|
Mar. 22, 2013
2013 PIPE investors [Member]
|
Jun. 30, 2013
2013 PIPE investors [Member]
|
Jun. 30, 2013
The Frost Group [Member]
|
Jun. 30, 2013
Mr.Spragens [Member]
|
Jan. 08, 2008
Maximum [Member]
|
Jan. 08, 2008
Minimum [Member]
|
Jan. 08, 2008
Common Stock [Member]
|
Sep. 30, 2007
Common Stock [Member]
Cellular [Member]
|
Dec. 31, 2010
Preferred Stock [Member]
|
Dec. 31, 2008
Preferred Stock [Member]
|
Jan. 08, 2008
Preferred Stock [Member]
|
|
Basis of Presentation and Liquidity (Textual) [Abstract] | |||||||||||||||||
Common stock, shares issued | 11,256,369 | ||||||||||||||||
Capital stock, share authorized | 250,000,000 | 35,000,000 | |||||||||||||||
Agreed to purchase an aggregate shares of common stock | 225,000,000 | 225,000,000 | 225,000,000 | ||||||||||||||
Common Stock at Par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||||
Preferred Stock, Par value | $ 0.01 | ||||||||||||||||
Series A Preferred stock aggregate issuance | 25,000,000 | ||||||||||||||||
Accumulated deficit | $ 31,000,000 | ||||||||||||||||
Basis of Warrant to Purchase Common Stock, Description | one warrant for every two common shares | ||||||||||||||||
Expiration Period | 5 years | ||||||||||||||||
Issuance of common shares in private offering,Shares | 20,794,000 | 12,100,000 | |||||||||||||||
Stock Issued During Period, Value, New Issues | 4,974,000 | 3,988,000 | 3,000,000 | 0 | 0 | ||||||||||||
Equity Issuance, Per Share Amount | $ 0.25 | ||||||||||||||||
Class Of Warrant Or Right, Number Of Securities Called By Warrants Or Rights | 6,050,000 | ||||||||||||||||
Warrant Exercise Price | $ 0.33 | ||||||||||||||||
Shares offered To Purchased | 50.00% | ||||||||||||||||
Debt Instrument, Annual Principal Payment | 1,100,000 | ||||||||||||||||
Line Of Credit Facility, Maximum Borrowing Capacity | $ 4,000,000 | $ 3,900,000 | $ 100,000 |
BASIS OF PRESENTATION AND LIQUIDITY
|
6 Months Ended |
---|---|
Jun. 30, 2013
|
|
Basis Of Presentation and Liquidity [Abstract] | |
BASIS OF PRESENTATION AND LIQUIDITY | NOTE 1 BASIS OF PRESENTATION AND LIQUIDITY The following (a) condensed consolidated balance sheet as of December 31, 2012, which has been derived from audited financial statements, and (b) the unaudited condensed consolidated interim financial statements of SafeStitch Medical, Inc. (“SafeStitch” or the “Company”) have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and the instructions to Form 10-Q and Rule 8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results and cash flows for the six months ended June 30, 2013 are not necessarily indicative of results that may be expected for the year ending December 31, 2013 or for future periods. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2012 included in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (“SEC”) on April 1, 2013. SafeStitch Medical, Inc. (together with its consolidated subsidiaries, “SafeStitch” or the “Company”) is a developmental stage medical device company focused on the development of medical devices that manipulate tissues for endoscopic and minimally invasive surgery for the treatment of obesity, gastroesophageal reflux disease (“GERD”), Barrett’s Esophagus, esophageal obstructions, upper gastrointestinal bleeding, hernia formation and other intraperitoneal abnormalities. Cellular Technical Services Company, Inc. (“Cellular”), a non-operating public company, was incorporated in 1988 as NCS Ventures Corp. under the laws of the State of Delaware. On July 25, 2007 Cellular entered into a Share Transfer, Exchange and Contribution Agreement (the “Share Exchange”) with SafeStitch LLC, a Virginia limited liability company. On September 4, 2007, Cellular acquired all of the members’ equity interests in SafeStitch LLC in exchange for 11,256,369 shares of Cellular’s common stock, which represented a majority of Cellular’s outstanding shares immediately following the Share Exchange. Effective January 8, 2008, Cellular changed its name to SafeStitch Medical, Inc. and increased the aggregate number of shares of capital stock that may be issued from 35,000,000 to 250,000,000, comprising 225,000,000 shares of common stock, par value $0.001 per share (the “Common Stock”), and 25,000,000 shares of preferred stock, par value $0.01 per share. For accounting purposes, the acquisition has been treated as a recapitalization of SafeStitch LLC, with SafeStitch LLC as the acquirer (reverse acquisition). The historical financial statements prior to September 4, 2007 are those of SafeStitch LLC, which began operations on September 15, 2005. The accompanying financial statements give retroactive effect to the recapitalization as if it had occurred on September 15, 2005 (inception). The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. For the period from September 15, 2005 (inception) through June 30, 2013, the Company has accumulated a deficit of $31.0 million and has not generated positive cash flows from operations. On March 22, 2013, the Company sold approximately 12,100,000 shares of our common stock (the "2013 PIPE Shares") in a private placement at a price of $0.25 per share, with net proceeds to the Company of approximately $3.0 million (Note 6). Included in this private placement was the issuance of warrants (the “PIPE Warrants”) to purchase approximately 6,050,000 common shares, representing one warrant for every two common shares purchased, with an exercise price of $0.33 per share and five year expiration. Approximately 50% of the shares and warrants offered were purchased by our officers, directors and significant shareholders. The capital raised will be primarily used for the expansion of our Gastroplasty Device study in Hungary, continued development of the Gastroplasty Device and sales and marketing efforts for the AMID® Hernia Fixation Device (the “AMID HFD”). Approximately $1.1 million of the proceeds was used to pay off amounts outstanding under the Credit Facility and promissory notes. Based upon the Company’s current cash position and by monitoring our discretionary expenditures, the Company will likely be able to fund operations through the end of this year. We based this belief on assumptions that may prove to be wrong or are subject to change, and we may be required to use our available cash resources sooner than we currently expect. Beyond this year, the Company will need to raise additional funds in order to continue its operations. In connection with the acquisition of SafeStitch LLC, the Company entered into a Note and Security Agreement (the “Credit Facility”) with both The Frost Group and Jeffrey G. Spragens, the Company’s Chief Executive Officer and President and a director. The Frost Group is a Florida limited liability company whose members include Frost Gamma Investments Trust (“Frost Gamma”), a trust controlled by Dr. Phillip Frost, one of the largest beneficial holders of the issued and outstanding shares of Common Stock, Dr. Jane H. Hsiao, the Company’s Chairman of the Board, and Steven D. Rubin, a director. The Credit Facility provided $4.0 million in total available borrowings, consisting of $3.9 million from The Frost Group and $100,000 from Mr. Spragens (see Note 5). The Credit Facility was not extended beyond its June 30, 2013 maturity date and additional funding will be required to continue operations. We intend to seek external financing for our future cash needs through public or private equity offerings, debt financings, strategic alliance or corporate collaboration and licensing arrangements. The Company currently does not have any commitments for future external funding. Almost all of the Company’s equity and financing to date has been provided from the Company’s principal existing stockholders and there is no assurance that the Company’s stockholders will continue to provide the necessary financing for us to continue our operations or that any additional equity or debt financing will be available to the Company on acceptable terms, or at all. If adequate funds are not available when needed, the Company may be required to delay, further reduce the scope of or eliminate our research and development programs, including the development of the Gastroplasty Device, all of which may not significantly extend the period of time that the Company will be able to continue operations without raising additional funding. It is uncertain as to the length of time the Company can sustain continued operations without the availability of additional. This uncertainty raises substantial doubt about the Company’s ability to continue as a going concern. The Company’s financial statements do not include any adjustments that might result from the outcome of this uncertainty. |