FRANKLIN, Mass., May 17 /PRNewswire-FirstCall/ -- Echo Therapeutics, Inc. (OTC Bulletin Board: ECTE), a company developing its needle-free Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and its Prelude™ SkinPrep System for transdermal drug delivery, today announced financial results for the period ended March 31, 2010.
Recent Corporate Highlights:
- In April, Echo Therapeutics and Ferndale Pharma Group initiated a clinical trial for Echo's Prelude SkinPrep System for the topical delivery of Lidocaine cream. Upon completion of this study, it is anticipated that Ferndale will submit a 510(k) premarket notification to the United States Food and Drug Administration (FDA) with subsequent commercial launch of the product after 510(k) clearance.
- Echo Therapeutics' needle-free Symphony tCGM System was featured in a March 31, 2010 online article in Scientific American Magazine entitled "This Really Won't Hurt a Bit: Wireless Sensor Promises Diabetics Noninvasive Blood Sugar Readings," which discusses the importance of continuous glucose monitoring.
- In February 2010, Echo Therapeutics, Inc. announced an additional advance in the product design of Symphony with the development of its next generation electronic component package. This important advance includes an initial 33% reduction in component size and improved architectural design as compared to the prototype electronic package of the Company's earlier Symphony tCGM device.
- In January 2010, Echo Therapeutics completed the product development work for its Prelude SkinPrep System and now has the commercially ready product to be used in the Ferndale clinical trial. In this announcement, management indicated that no further changes will be made to the Prelude SkinPrep System and that the current device will be the one used for sale, subject to FDA market clearance of the product.
"We continue to exploit the tangible progress we made during 2009 and achieved some very important milestones, including our announcement that the first patients were enrolled in a clinical study of our Prelude SkinPrep System with our partner Ferndale Pharma Group," commented Patrick T. Mooney, M.D., Chairman and Chief Executive Officer of Echo Therapeutics. "This clinical study is designed to evaluate the ability of the Prelude SkinPrep System to ablate the skin prior to application of OTC lidocaine cream for local dermal anesthesia. Upon completion of this study, we anticipate that Ferndale will submit a 510(k) premarket notification to the United States Food and Drug Administration (FDA) with subsequent commercial launch of the product after 510(k) clearance."
First quarter 2010 financial results
For the first quarter of 2010, Echo reported approximately $14,000 in licensing revenue compared to no revenue in the first quarter of 2009. The Company increased operating expenses by 178% to $2.4 million compared to $0.9 million during the first quarter of 2009. This increase included a 286% increase in research and development and a 123% increase in selling, general and administrative expenses. The net loss for the first quarter was $1.9 million, or ($0.07) per share, compared to a net loss of $1.3 million, or ($0.07) per share last year. The Company completed the quarter with cash of $1.9 million, after the Company raised an additional $2.5 million in cash from the issuance of Common Stock and warrants during the quarter.
2010 Outlook
Echo Therapeutics management reiterated its expectations for the 2010 outlook:
"We are focused on completing several key milestones during 2010 that will enable the company to begin generating near-term revenue," Dr. Mooney concluded. "This includes the successful advancement of a clinical trial study with our Symphony system, which incorporates our Prelude SkinPrep System, substantially the same System that is being used in the Ferndale clinical trial for enhanced delivery of lidocaine. We anticipate securing additional strategic partner licensing arrangements while we begin manufacturing scale-up for Prelude's product validation and planned product launch in late 2010."
About Echo Therapeutics
Echo is developing the Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system for use in hospital critical care units and for patients with diabetes. Echo is also developing its needle-free Prelude SkinPrep System as a platform technology for enhanced skin permeation for transdermal drug delivery of a wide range of novel topical reformulations of widely-used, FDA-approved products.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo's and its licensees' ongoing studies, including the efficacy of Echo's Symphony tCGM and Prelude SkinPrep Systems, the failure of future development and preliminary marketing efforts related to Echo's Symphony tCGM and Prelude SkinPrep Systems, Echo's ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo's and its licensees' ability to develop, market and sell diagnostic and transdermal drug delivery products based on its skin permeation platform technologies, including the Symphony tCGM and Prelude SkinPrep Systems, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its Symphony tCGM and Prelude SkinPrep Systems. These and other risks and uncertainties are identified and described in more detail in Echo's filings with the Securities and Exchange Commission, including, without limitation, its annual report on Form 10-K for the year ended December 31, 2009, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.
For More Information: | ||
Patrick T. Mooney, M.D. | Jeffrey Stanlis | |
Chairman and Chief Executive Officer | Partner, Hayden IR | |
(508)-530-0329 | (602) 476-1821 | |
Tables to Follow | |
Echo Therapeutics, Inc. Consolidated Balance Sheets | |||||||||
As of, | |||||||||
March 31, | December 31, | ||||||||
2010 | 2009 | ||||||||
ASSETS | Unaudited | ||||||||
Current Assets: | |||||||||
Cash and cash equivalents | $ 1,897,238 | $ 1,166,858 | |||||||
Accounts receivable | - | 130,036 | |||||||
Prepaid expenses and other current assets | 283,413 | 226,641 | |||||||
Total current assets | 2,180,651 | 1,523,535 | |||||||
Property and Equipment, at cost: | |||||||||
Computer equipment | 262,958 | 262,278 | |||||||
Office and laboratory equipment (including assets under capitalized leases) | 618,723 | 618,723 | |||||||
Furniture and fixtures | 14,288 | 14,288 | |||||||
Manufacturing equipment | 129,320 | 129,320 | |||||||
Leasehold improvements | 177,768 | 177,768 | |||||||
1,203,057 | 1,202,377 | ||||||||
Less-Accumulated depreciation and amortization | (1,151,398) | (1,143,167) | |||||||
Net property and equipment (including assets under capitalized leases) | 51,659 | 59,210 | |||||||
Other Assets: | |||||||||
Restricted cash | 9,749 | 9,749 | |||||||
Intangible assets, net of accumulated amortization | 9,679,239 | 9,708,822 | |||||||
Deposits and other assets | 2,000 | 2,000 | |||||||
Total other assets | 9,690,988 | 9,720,571 | |||||||
Total assets | $ 11,923,298 | $ 11,303,316 | |||||||
As of, | ||||||||
March 31, | December 31, | |||||||
2010 | 2009 | |||||||
Unaudited | ||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ 925,057 | $ 948,712 | ||||||
Deferred revenue | 551,982 | 591,051 | ||||||
Current portion of capital lease obligation | 1,921 | 1,874 | ||||||
Derivative warrant liability | 1,620,351 | 2,116,696 | ||||||
Accrued expenses and other liabilities | 166,414 | 481,679 | ||||||
Total current liabilities | 3,265,725 | 4,140,012 | ||||||
Capital lease obligation, net of current portion | 7,749 | 8,247 | ||||||
Deferred revenue, net of current portion | 147,550 | 122,451 | ||||||
Total liabilities | 3,421,024 | 4,270,710 | ||||||
Commitments | ||||||||
Stockholders' Equity: | ||||||||
Perpetual, Redeemable Preferred Stock: | ||||||||
Series B, authorized 40,000 shares, issued and outstanding 144.0140 and 141.2281 shares at March 31, 2010 and December 31, 2009, respectively (preference in liquidation of $1,440,140 at March 31, 2010) | 2 | 2 | ||||||
Convertible Preferred Series: | ||||||||
Series C, authorized 10,000 shares, issued and outstanding 4,918.1 shares at March 31, 2010 and December 31, 2009 | 49 | 49 | ||||||
Common stock, $0.01 par value, authorized 100,000,000 shares, issued and outstanding 29,053,245 and 27,045,792 shares at March 31, 2010 and December 31, 2009, respectively | 290,534 | 270,459 | ||||||
Additional paid-in capital | 77,486,855 | 74,155,716 | ||||||
Accumulated deficit | (69,275,166) | (67,393,620) | ||||||
Total stockholders' equity | 8,502,274 | 7,032,606 | ||||||
Total liabilities and stockholders' equity | $ 11,923,298 | $ 11,303,316 | ||||||
Echo Therapeutics, Inc. Consolidated Statements of Operations Unaudited | |||||||
Three Months Ended | |||||||
March 31, | |||||||
2010 | 2009 | ||||||
Licensing revenue | $ 13,972 | $ - | |||||
Operating Expenses: | |||||||
Research and development | 1,113,485 | 288,216 | |||||
Selling, general and administrative | 1,277,623 | 573,364 | |||||
Total operating expenses | 2,391,108 | 861,580 | |||||
Loss from operations | (2,377,136) | (861,580) | |||||
Other Income (Expense): | |||||||
Interest income | 691 | 389 | |||||
Interest expense | (1,089) | (178,707) | |||||
Gain on extinguishment of financial advisor fee payable | 200,000 | - | |||||
Derivatives gain (loss) | 295,988 | (251,432) | |||||
Other income (expense), net | 495,590 | (429,750) | |||||
Net loss | (1,881,546) | (1,291,330) | |||||
Accretion of dividends on Convertible Preferred Stock | -- | (57,674) | |||||
In-kind dividends on Perpetual Redeemable Preferred Stock | (27,859) | -- | |||||
Net loss applicable to common shareholders | $ (1,909,405) | $ (1,349,004) | |||||
Net loss per common share, basic and diluted | $ (0.07) | $ (0.07) | |||||
Basic and diluted weighted average common shares outstanding | 28,242,669 | 19,380,146 | |||||
SOURCE Echo Therapeutics, Inc.
