FRANKLIN, Mass., Aug. 17 /PRNewswire-FirstCall/ -- Sontra Medical
Corporation (Nasdaq SC: SONT) announced today financial results for the second
quarter and six months ended June 30, 2004. For the three months ended June
30, 2004, the net loss applicable to common stockholders was $1,407,000, or
$.09 per share, as compared to $1,061,000, or $.11 per share, for the same
period in 2003. For the six months ended June 30, 2004, the net loss
applicable to common stockholders was $2,810,000, or $.19 per share, as
compared to $2,012,000, or $.21 per share, for the same period in 2003.
"We continue to invest in the development of additional product
applications for our SonoPrep ultrasonic skin permeation platform such as
transdermal drug delivery, including vaccines and other pain drugs, and non-
invasive continuous glucose monitoring, which address a combined market
opportunity in excess of $8 billion," Thomas W. Davison, PhD, chief executive
officer of Sontra, commented. "We are eagerly awaiting marketing clearance
from the FDA for SonoPrep and a procedure tray for use with topical lidocaine
to achieve rapid skin anesthesia. In June, we hired Barry D. Marston, our new
Vice President of Sales and Marketing, and we believe he will be instrumental
in our efforts to successfully launch SonoPrep into the $100 million topical
lidocaine market."
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
Sontra filed for a FDA 510(k) submission in March 2004 seeking FDA market
clearance for the SonoPrep device and procedure tray for use with topical
lidocaine to achieve rapid skin anesthesia. In June 2004, the Company filed
additional information in support of the 510(k) submission. The 510(k)
submission is supported by clinical data from three studies involving
approximately 500 patients that demonstrated that rapid skin anesthesia with
4% lidocaine was achieved within five minutes following a skin pretreatment
with SonoPrep.
Vaccine Delivery
Recently completed animal studies demonstrated that SonoPrep skin
permeation technology facilitates the transdermal delivery of tetanus vaccine
to invoke an immune response without the use of a toxin adjuvant. SonoPrep
disrupts the stratum corneum and has the potential to precisely deliver
vaccines to the viable epidermis to activate the Langerhan cells which invoke
a powerful immune response. Sontra plans to conduct Phase I human studies
later this year that will investigate the use of SonoPrep to deliver a flu
vaccine through the skin.
Systemic Delivery of Pain Drugs
Sontra's clinical studies with topical lidocaine demonstrate that SonoPrep
can greatly accelerate the onset of action for currently approved transdermal
drugs. Following up on these clinical studies, Sontra expects to build on its
pain product portfolio to demonstrate that SonoPrep can enhance the delivery
of systemic transdermal pain drugs. Sontra plans to initiate a Phase 1 human
study later this year that will investigate the use of SonoPrep to accelerate
the onset time of transdermal fentany(l) which is a powerful opiate that
requires up to an 18-hour period before effective analgesia is achieved and is
frequently administered to patients with chronic cancer pain.
Non-Invasive Diagnostics-Continuous Glucose Monitoring
SonoPrep skin permeation technology increases transdermal molecular
transport so that sufficient samples of analytes such as glucose can be
continuously collected and measured. Our non-invasive glucose monitor is being
developed to continuously measure glucose levels in diabetic patients and
addresses the unmet need in the $5 billion home testing market for a truly
continuous and non-invasive glucose monitor. Our glucose monitoring system
consists of the SonoPrep skin permeation device and a glucose biosensor/patch
placed over the permeated skin site that continuously measures the glucose as
it flows into the sensor.
In July 2003 Sontra and the Bayer Health Care LLC Diagnostic Division
executed a license agreement under which Sontra granted Bayer an exclusive
worldwide right and license to the Company's glucose monitoring technology.
During 2003 Sontra completed a Phase 1 clinical study in ten diabetic
patients. The study was conducted with the SonoPrep device and Sontra's first
glucose biosensors and meters. Over 5,000 data points per sensor were
collected and analyzed per sensor. Data sets comparing blood glucose
measurements to data collected from the Symphony biosensor had an 84(r=.84)
correlation to glucose measurements. During 2004, the Company improved the
design of the biosensor and expects to conduct a second study in diabetics in
the fall of 2004.
About Sontra Medical Corporation (http://www.sontra.com)
Sontra Medical Corporation is a leading developer of transdermal drug
delivery and diagnostic products that combine Sontra's SonoPrep ultrasound-
mediated skin permeation technology with synergistic biosensor and transdermal
drug delivery technologies. Products under development include: SonoPrep and a
procedure tray for rapid (within five minutes) skin anesthesia; a continuous
non-invasive glucose monitor developed in collaboration with Bayer Diagnostics
and the use of SonoPrep for the transdermal delivery of vaccines and large
molecule drugs.
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 timing of the
commercial availability of the SonoPrep device and procedure tray, the
expected benefits and market opportunities of the SonoPrep device and
technology, the expected size of the markets for the SonoPrep device and
procedure tray, Sontra's expected ability to commercialize additional
products, and Sontra's business 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
and commercialization efforts; difficulties or delays in obtaining regulatory
approvals to market products resulting from development efforts; difficulties
or delays associated with sources of topical lidocaine; failure to obtain and
maintain patent protection for discoveries; commercial limitations imposed by
patents owned or controlled by third parties; dependence upon strategic
partners to develop and commercialize 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 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.
SONTRA MEDICAL CORPORATION
Consolidated Statements of Loss
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2004 2003 2004 2003
Product revenues $2,500 $- $2,500 $-
Cost of product sales 801 - 801 -
Gross margin 1,699 - 1,699 -
Operating Expenses:
Research and
development 662,617 432,496 1,338,524 973,848
General and
administrative 566,202 631,792 1,093,696 1,050,225
Total operating
expenses 1,228,819 1,064,288 2,432,220 2,024,073
Loss from
operations (1,227,120) (1,064,288) (2,430,521) (2,024,073)
Interest income 17,528 3,031 31,757 12,137
Net loss (1,209,592) (1,061,257) (2,398,764) (2,011,936)
Accretion of dividend
and beneficial
conversion feature
on Series A
Convertible
Preferred Stock (197,539) - (410,973) -
Net loss applicable to
common shareholders $(1,407,131) $(1,061,257) $(2,809,737)$(2,011,936)
Net loss per common
share, basic and
diluted $(0.09) $(0.11) $(0.19) $(0.21)
Basis and diluted
weighted average
common shares
outstanding 16,146,758 9,376,808 14,428,905 9,368,917
SONTRA MEDICAL CORPORATION
Consolidated Balance Sheets
As of
June 30, December 31,
2004 2003
(Unaudited)
Assets:
Current Assets:
Cash and cash equivalents $5,672,818 $4,868,933
Accounts receivable - 1,500,000
Prepaid expenses and other current
assets 79,053 66,075
Total current assets 5,751,871 6,435,008
Property and Equipment, at cost
Computer equipment 186,637 171,272
Office and laboratory equipment 476,604 405,285
Furniture and fixtures 14,288 14,288
Manufacturing equipment 180,608 144,695
Leasehold improvements 174,698 166,289
1,032,835 901,829
Less-Accumulated depreciation and
amortization (576,510) (498,341)
Net property and equipment 456,325 403,488
Other Assets:
Restricted cash 48,746 48,746
Other assets 2,000 2,000
Total other assets 50,746 50,746
Total assets $6,258,942 $6,889,242
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable $137,518 $136,810
Accrued expenses 314,583 465,092
Total current liabilities 452,101 601,902
Commitments
Stockholders' Equity
Series A Convertible Preferred
Stock, $0.01 par value,
authorized
7,000,000 shares, issued and
outstanding 73,334 shares at
June 30, 2004 and 6,495,000
shares at December 31, 2003
(preference in liquidation of
$77,817) 77,817 6,628,842
Common stock, $0.01 par value,
authorized 40,000,000 shares,
issued
and outstanding 18,012,683
shares at June 30, 2004 and
10,102,992
shares at December 31, 2003 180,127 101,030
Additional paid-in capital 26,320,633 17,952,721
Deferred stock-based compensation (350,593) (372,874)
Accumulated deficit (20,421,143) (18,022,379)
Total stockholders' equity 5,806,841 6,287,340
Total liabilities and stockholders'
equity $6,258,942 $6,889,242
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
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 of
KCSA Worldwide
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