FRANKLIN, Mass., Nov. 11 /PRNewswire-FirstCall/ -- Sontra Medical
Corporation (Nasdaq SC: SONT) announced today financial results for the third
quarter and nine months ended September 30, 2004. For the three months ended
September 30, 2004, the net loss applicable to common stockholders was
$1,302,000, or $.07 per share, as compared to $1,351,000, or $.14 per share,
for the same period in 2003. For the nine months ended September 30, 2004, the
net loss applicable to common stockholders was $4,112,000, or $.26 per share,
as compared to $3,363,000, or $.36 per share, for the same period in 2003.
Sontra's cash on hand at September 30, 2004 increased by $601,000 from the end
of the previous quarter to $6,274,000. During the quarter the Company received
$1,666,000 in proceeds from the exercise of warrants and has the potential to
receive an additional $8,363,000 upon the exercise of outstanding warrants to
purchase 5,659,000 shares of common stock with exercise prices ranging from
$1.20-$1.50 per share.
"We are very pleased with our performance and progress over the last
quarter," Thomas W. Davison, PhD, chief executive officer of Sontra,
commented. "We received FDA clearance and commenced the market launch of the
SonoPrep skin permeation device and procedure tray for rapid skin anesthesia.
We also completed two successful human clinical trials in transdermal
vaccination and continuous non-invasive glucose monitoring, both of which
provide us with the confidence that the benefits of SonoPrep will contribute
to two significant health care challenges. We will continue to invest in the
development of these applications as well as the transdermal drug delivery of
large molecule drugs. These products address a combined market opportunity in
excess of $8 billion and we plan on changing the transdermal drug delivery
paradigm and becoming the first company to deliver large molecular weight
drugs through the skin."
Product Update
Transdermal Drug Delivery
The SonoPrep skin permeation technology increases skin permeability 100
fold compared to untreated skin, enabling the delivery of large molecule drugs
and vaccines through the skin. SonoPrep can improve the delivery of currently
approved transdermal drugs and make possible the transdermal delivery of large
protein biopharmaceuticals that to date due to their large molecular sizes
have not been delivered through the skin.
Topical Lidocaine
In August 2004, Sontra received FDA marketing clearance for the SonoPrep
device and procedure tray for use with topical lidocaine to achieve rapid skin
anesthesia (within 5 minutes). The Company commenced the market launch into
this $100 million market in September 2004.
Transdermal Vaccine Delivery
SonoPrep disrupts the stratum corneum and has the potential to precisely
deliver vaccines to the viable epidermis to activate the dendritic Langerhan
cells which invoke a powerful immune response. The Company is developing a
universal patch/reservoir delivery system for the transdermal delivery of
vaccines. In October 2004, the Company completed a twenty patient human
clinical study conducted at the University of Massachusetts that demonstrated
that SonoPrep facilitated the transdermal delivery of large molecular weight
antigenic proteins; tetanus toxoid and candida albicans (yeast) to induce a
skin immune response. Building on this study, the Company plans to complete a
second study at University of Massachusetts using SonoPrep to deliver the
hepatitis B vaccine through the skin.
Continuous Non-Invasive Glucose Monitoring System
Sontra is developing a non-invasive glucose monitoring system that
continuously measures glucose levels in patients with diabetes and addresses
the unmet need in the $5 billion home testing market for a truly continuous
and non-invasive glucose monitor. Sontra's glucose monitoring system consists
of the SonoPrep skin permeation device and a glucose flux biosensor placed
over the permeated skin site that continuously measures the glucose as it
flows into the sensor.
In November 2004, Sontra announced clinical results that demonstrated its
glucose monitoring system reliably detected real-time changes in the blood
glucose levels of patients with diabetes. The study was conducted at
Vanderbuilt University and included twelve adult participants with either Type
1 or Type 2 diabetes. Each participant had three glucose flux biosensors
placed on their skin, allowing over 2,000 glucose measurements to be collected
every five seconds over an eight hour period. Completed data showed a 90
percent(r=.90) to reference blood glucose measurements. Sontra's glucose flux
biosensor successfully measured glucose readings over a wide range and was
able to predict hypoglycemic events (blood glucose<70 mg/dl). The accuracy of
the glucose monitor in this study was superior to the Medtronic MiniMed
implantable CGMS sensor (n=23) and Cygnus Glucowatch-2(n=13).
Conference Call Information
Sontra will host a live conference call and listen-only Webcast on
Thursday, November 11, 2004 at 11 a.m. ET to provide a business update and
discuss its third quarter 2004 financial results.
To participate in the conference call, please dial: 1-973-409-9259.
A listen-only Webcast of the conference call will be available at
http://www.viavid.net/detailpage.aspx?sid=0000202C
In addition, a replay of the live Webcast will be 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 initial human
clinical trials at leading universities and medical centers for several
billion dollar market opportunities including that 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 vaccine delivery, glucose monitoring and
large molecular weight drug delivery, the expected benefits, market
opportunities 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 and marketing 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 and market
acceptance; difficulties or delays in obtaining regulatory approvals to market
products resulting from development efforts; difficulties or delays associated
with sources of 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 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
Quarterly Report on Form 10-QSB. 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, CFO or Evan Smith, CFA / Erica Pettit
Sontra Medical Corporation KCSA Worldwide
Tel: 508-553-8850 Tel: 212-896-1251 / 212-896-1248
SONTRA MEDICAL CORPORATION
Consolidated Statements of Operations
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2004 2003 2004 2003
Product revenue $12,254 $ - $ 14,754 $ -
Licensing revenue - 1,500,000 1,500,000
Total revenue 12,254 1,500,000 14,754 1,500,000
Cost of product sales 5,523 - 6,324 -
Gross margin 6,731 1,500,000 8,430 1,500,000
Operating Expenses:
Research and
development 726,261 509,143 2,064,785 1,482,991
Selling, general and
administrative 598,265 137,705 1,691,961 1,187,930
Total operating
expenses 1,324,526 646,848 3,756,746 2,670,921
Income (loss) from
operations (1,317,795) 853,152 (3,748,316) (1,170,921)
Interest income 17,503 2,357 49,260 14,494
Net income
(loss) (1,300,292) 855,509 (3,699,056) (1,156,427)
Accretion of dividend
and beneficial
conversion feature
on Series A
Convertible Preferred
Stock (1,479) (2,206,371) (412,452) (2,206,371)
Net loss applicable
to common
shareholders $(1,301,771) $(1,350,862) $(4,111,508) $(3,362,798)
Net loss per common
share, basic
and diluted $ (0.07) $ (0.14) $ (0.26) $ (0.36)
Basic and diluted
weighted average
common shares
outstanding 18,339,590 9,411,395 15,741,981 9,383,232
SONTRA MEDICAL CORPORATION
Consolidated Balance Sheets
As of
September 30, December 31,
2004 2003
(Unaudited)
ASSETS
Current Assets:
Cash and cash equivalents $6,273,632 $4,868,933
Accounts receivable 12,254 1,500,000
Inventory 18,849 -
Prepaid expenses and other current assets 56,441 66,075
Total current assets 6,361,176 6,435,008
Property and Equipment, at cost
Computer equipment 207,842 171,272
Office and laboratory equipment 483,291 405,285
Furniture and fixtures 14,288 14,288
Manufacturing equipment 182,210 144,695
Leasehold improvements 174,698 166,289
1,062,329 901,829
Less-Accumulated depreciation and
amortization (615,240) (498,341)
Net property and equipment 447,089 403,488
Other Assets:
Restricted Cash 48,746 48,746
Other Assets 2,000 2,000
Total other assets 50,746 50,746
Total assets $6,859,011 $6,889,242
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable $177,121 $136,810
Accrued expenses 352,234 465,092
Total current liabilities 529,355 601,902
Commitments
Stockholders' Equity
Series A Convertible Preferred Stock,
$0.01 par value, authorized 7,000,000
shares, issued and outstanding 73,334
shares at September 30, 2004 and
6,495,000 shares at December 31,
2003 (preference in liquidation
of $79,296) 79,296 6,628,842
Common stock, $0.01 par value, authorized
40,000,000 shares, issued and
outstanding 19,164,423 shares at September
30, 2004 and 10,102,992 shares at December
31, 2003 191,644 101,030
Additional paid-in capital 28,134,533 17,952,721
Deferred stock-based compensation (354,382) (372,874)
Accumulated deficit (21,721,435) (18,022,379)
Total stockholders' equity 6,329,656 6,287,340
Total liabilities and stockholders' equity $6,859,011 $6,889,242
SOURCE Sontra Medical Corporation
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Related links:
http://www.sontra.com
CONTACT:
Sean Moran, CFO of Sontra Medical
Corporation, +1-508-553-8850; or Evan Smith, CFA,
+1-212-896-1251, or Erica Pettit, +1-212-896-1248, both of KCSA
Worldwide
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