FRANKLIN, Mass., Feb. 16 /PRNewswire-FirstCall/ -- Sontra Medical
Corporation (Nasdaq: SONT) announced today financial results for the fourth
quarter and fiscal year ended December 31, 2004. For the three months ended
December 31, 2004, the net loss applicable to common stockholders was
$1,663,000, or $.08 per share, as compared to $2,794,000, or $.29 per share,
for the same period in 2003. For the year ended December 31, 2004, the net
loss applicable to common stockholders was $5,774,000, or $.34 per share, as
compared to $6,156,000, or $.65 per share, in 2003. The Company completed a $4
million equity financing in December and ended the year with $9,515,000 in
cash with no debt. The Company expects that its cash on hand will be
sufficient to fund operations through at least June 2006.
Product Highlights:
SonoPrep(R) and Procedure Tray for Topical Lidocaine:
* Seven regional distributors with sales representatives covering
approximately 70% of hospital market are now selling SonoPrep.
* Signed U.S. distribution agreement with VNUS Medical Technologies for
the varicose vein market.
* A combined sales force of 100 representatives now promotes SonoPrep.
* SonoPrep featured in Time Magazine, Reader's Digest, Popular Science,
Health Magazine and Contemporary Pediatrics.
* Completed two successful clinical trials in pediatric patients, the
largest immediate target market for SonoPrep.
Continuous Non-Invasive Glucose Monitoring System
* Completed successful human clinical trial and system reliably detected
real time changes in glucose (correlation of 90%).
Transdermal Vaccination:
* Completed successful human trial at UMASS Medical Center lemonstrating
that SonoPrep facilitated the transdermal delivery of large antigenic
proteins to induce an immune response.
"We have made significant progress rolling out the SonoPrep product for
the $100 million topical lidocaine market and in the development of other
transdermal products," stated Thomas W. Davison, PhD, Sontra's President and
Chief Executive Officer. "We are working closely with our new SonoPrep
distributors and expect to have full U.S. distribution in place as planned by
June 2005. We have improved the accuracy and reliability of our continuous
non-invasive glucose monitoring system and the results of our October 2004
human clinical study conducted at Vanderbilt University clearly demonstrated
the potential of our enabling technology. In that study, our system was more
accurate than the MiniMed implantable sensor and the Cygnus GlucoWatch,
especially in the detection of hypoglycemia. We have refined our product
strategy and are now developing a continuous glucose monitor for post-surgical
intensive care. The hospital product is being developed in parallel with the
home testing and physician diabetes management products. During 2005, we
expect to complete product definition and begin product development so that we
can commence pivotal FDA clinical studies and potentially launch the hospital
product by the end of 2006."
Dr. Davison added, "For transdermal vaccination, we expect to commence two
additional human clinical studies during the first half of 2005, a hepatitis A
vaccine study at UMASS Medical Center and a flu vaccine study at St. Louis
University. Based on our initial clinical results, we are confident that the
SonoPrep technology can address major health challenges of the $5 billion
glucose testing market and the $3 billion vaccine market. We also believe we
have the potential to change the existing transdermal(drug delivery model and
be the first company to deliver large molecular weight drugs through the
skin."
Conference Call Information
Sontra will host a live conference call and listen-only Webcast on
Thursday, February 17, 2005 at 11 a.m. ET to provide a business update and
discuss its fourth quarter and fiscal year 2004 financial results.
To participate in the conference call, please dial: 1-973-409-9259.
A listen-only Webcast and replay of the conference call are available at
http://www.sontra.com.
About Sontra Medical Corporation (http://www.sontra.com)
Sontra Medical Corporation is a technology leader in transdermal science.
Sontra's SonoPrep ultrasound-mediated skin permeation technology combined with
technical competencies in transdermal drug formulation, delivery systems and
biosensors is creating a new paradigm in transdermal drug delivery and
diagnosis. The SonoPrep technology has demonstrated strong results from its
initial human clinical trials at leading universities and medical centers for
several billion dollar market opportunities including the transdermal delivery
of vaccines and large molecule drugs and continuous non-invasive glucose
monitoring. Sontra is currently marketing the SonoPrep device and procedure
tray for use with topical lidocaine to achieve rapid (within five minutes)
skin anesthesia.
SonoPrep is a registered trademark of Sontra Medical Corporation. All
other company, product or service names mentioned herein are the trademarks or
registered trademarks of their respective owners.
This press release contains forward-looking statements, which address a
variety of subjects including, for example, the expected efficacy of the
SonoPrep device in connection with diagnostics, vaccine delivery, glucose
monitoring and transdermal drug delivery, the expected benefits, market
opportunities, distribution(and market acceptance of the SonoPrep device and
technology, the expected size of the markets for the SonoPrep device and
technology, Sontra's expected ability to commercialize additional products,
and Sontra's business, research, marketing and distribution strategies and
product development plans. Statements that are not historical facts, including
statements about our beliefs and expectations, are forward-looking statements.
Such statements are based on our current expectations and are subject to a
number of factors and uncertainties, which could cause actual results to
differ materially from those described in the forward-looking statements. The
following important factors and uncertainties, among others, could cause
actual results to differ materially from those described in these forward-
looking statements: adverse results in product development, clinical trials,
commercialization efforts, product distribution and market acceptance;
dafficulties or delays in obtaining regulatory approvals to market products
resulting from development efforts; difficulties or delays associated with
sources of regulatory-approved transdermal drugs and vaccines; failure to
obtain and maintain patent protection for discoveries; commercial limitations
imposed by patents owned or controlled by third parties; dependence upon
strategic partners and third-party distributors to develop, commercialize,
market and sell products based on our work; the commercial success of
products; and the requirement for substantial funding to conduct research and
development and to expand commercialization, distribution and marketing
activities. For detailed information about factors that could cause actual
results to differ materially from those described in the forward-looking
statements, please refer to Sontra's filings with the Securities and Exchange
Commission, including Sontra's most recent Annual Report on Form 10-KSB.
Forward-looking statements represent management's current expectations and are
inherently uncertain. We do not undertake any obligation to update forward-
looking statements made by us.
Contacts:
Sean Moran, Sontra Medical CFO
508-553-8850 ext 234
or
Evan Smith, CFA / Erica Pettit, Financial Dynamics
212-850-5606 / 212-850-5614
SONTRA MEDICAL CORPORATION
Consolidated Statements of Loss
For the Years Ended For the Three Months Ended
December 31, December 31,
2004 2003 2004 2003
Product revenues $33,565 $ - $18,811 $ -
Licensing revenue - 1,500,000 - -
Total revenue 33,565 1,500,000 18,811 -
Cost of product
revenue 16,680 - 10,356 -
Gross margin 16,885 1,500,000 8,455 -
Operating Expenses:
Research and
development 3,039,450 2,265,519 974,665 782,528
Selling,
general and
administrative 2,423,806 1,740,555 731,845 552,625
Total operating
expenses 5,463,256 4,006,074 1,706,510 1,335,153
Loss from
operations (5,446,371) (2,506,074) (1,698,055) (1,335,153)
Interest income 86,189 26,620 36,929 12,126
Net loss (5,360,182) (2,479,454) (1,661,126) (1,323,027)
Accretion of
dividend and
beneficial
conversion
feature on
Series A
Convertible
Preferred Stock (413,901) (3,676,590) (1,449) (1,470,579)
Net loss
applicable
to common
shareholders $(5,774,083) $(6,156,044) $(1,662,575) $(2,793,606)
Net loss per
common share,
basic and diluted $(0.34) $(0.65) $(0.08) $(0.29)
Basic and diluted
weighted average
common shares
outstanding 16,763,798 9,467,912 19,840,477 9,719,192
SONTRA MEDICAL CORPORATION
Consolidated Balance Sheets
As of December 31,
2004 2003
Assets:
Current Assets:
Cash and cash equivalents $9,515,244 $4,868,933
Accounts receivable 16,821 1,500,000
Legal settlement receivable 250,000 -
Inventory, net 152,642 -
Prepaid expenses and other current
assets 69,492 66,075
Total current assets 10,004,199 6,435,008
Property and Equipment, at cost:
Computer equipment 206,970 171,272
Office and laboratory equipment 492,377 405,285
Furniture and fixtures 14,288 14,288
Manufacturing equipment 182,210 144,695
Leasehold improvements 174,698 166,289
1,070,543 901,829
Less-accumulated depreciation and
amortization (655,242) (498,341)
Net property and equipment 415,301 403,488
Other Assets:
Restricted cash 38,997 48,746
Other assets 2,000 2,000
Total assets $10,460,497 $6,889,242
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable $358,530 $136,810
Accrued expenses 759,051 465,092
Total current liabilities 1,117,581 601,902
Commitments
Stockholders' Equity
Series A Convertible Preferred
Stock, $0.01 par value,
authorized 7,000,000 shares,
issued and outstanding
73,334 shares at December
31,2004(preference in
liquidation of $76,291)
and 6,495,000 shares at
December 31, 2003 76,291 6,628,842
Common stock, $0.01 par value,
authorized 40,000,000 shares,
issued and outstanding
21,935,732 shares at December
31, 2004 and 10,102,992
shares at December 31, 2003 219,358 101,030
Additional paid-in capital 32,674,740 17,952,721
Deferred stock-based compensation (244,912) (372,874)
Accumulated deficit (23,382,561) (18,022,379)
Total stockholders' equity 9,342,916 6,287,340
Total liabilities and stockholders'
equity $10,460,497 $6,889,242
SOURCE Sontra Medical Corporation
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Related links:
http://www.sontra.com
CONTACT:
Sean Moran, CFO of Sontra Medical,
+1-508-553-8850 ext. 234; or Evan Smith, CFA, +1-212-850-5606, or
Erica Pettit, +1-212-850-5614, both of Financial Dynamics
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