FRANKLIN, Mass., Nov. 14 /PRNewswire-FirstCall/ -- Sontra Medical
Corporation (Nasdaq: SONT) announced financial results today for the three and
nine months ended September 30, 2005. For the three months ended September 30,
2005, the net loss applicable to common stockholders was $1,511,000, or $.07
per share, as compared to $1,302,000, or $.07 per share, for the same period
in 2004. For the nine months ended September 30, 2005, the net loss applicable
to common stockholders was $4,556,000, or $.21 per share, as compared to
$4,112,000, or $.26 per share, for the same period in 2004. The Company ended
the quarter with $5,282,000 in cash and short-term investments on hand and
expects that these funds will be sufficient to fund operations through at
least June 2006.
Third Quarter Product Highlights:
Continuous Transdermal Glucose Monitoring System
* Designed clinical protocols for hospital intensive care unit (ICU)
product; human trials to commence in 2006.
* Fabricated prototypes of new telemetry-based glucose flux biosensor and
wireless meter; patients with diabetes to be tested in early 2006.
* Completed ISO audit and recommended for ISO 13485 certification;
planning to achieve European CE mark approval for SonoPrep(R) skin
permeation device in 2006.
Transdermal Vaccination Facilitated by SonoPrep(R)
* Forged research partnership with EpiVax and commenced pre-clinical
studies using SonoPrep skin permeation device to deliver EpiVax's HIV
vaccine.
* Awarded grant from U.S. Army to investigate the use of SonoPrep to
deliver the dengue vaccine transdermally.
SonoPrep(R) and Procedure Tray for Topical Lidocaine
* Launched product to pediatric offices.
* Product evaluations continuing at large pediatric hospitals.
* Results from Hasbro pediatric clinical study accepted for publication in
the Pediatric Emergency Care journal.
Sontra is continuing to negotiate the terms of an agreement with Bayer
HealthCare LLC's Diabetes Care Division related to the continued development
of a continuous non-invasive glucose monitoring system. Such agreement is
expected to revise and define product development activities, deliverables,
milestones and payments, including the $3 million milestone payment upon
completion of Phase 1 of Bayer's development process. The Company expects to
execute this agreement during the fourth quarter of fiscal 2005 and will make
an announcement and conduct a conference call at that time.
"We are very pleased with the progress we have made in the development of
our continuous transdermal glucose monitor for the hospital ICU market,"
stated Thomas W. Davison, PhD, Sontra's President and Chief Executive Officer.
"We have completed the fabrication of our first prototypes so that validation
clinical studies in critical care can commence in 2006. Frequent glucose
monitoring and intensive insulin therapy have become a standard of care in
critical care medicine, as tight glucose control has been shown to
significantly reduce patient mortality, complications, hospital stay and cost.
As a result, intensive care nurses are measuring blood glucose for their
patients up to every hour in order to adjust insulin infusion rates.
Development of our critical care glucose monitor is proceeding in parallel
with the development of a product for the $5 billion diabetes home testing
market, as the product technologies are the same and designs are very
similar."
Dr. Davison continued, "In transdermal vaccination, the knowledge we
gained in our recently completed studies with the influenza and Hepatitis A
vaccines is helping us optimize the formulation and delivery of vaccines
through ultrasonically permeated skin. We recently developed research
partnerships with EpiVax and the U.S. Army, and we expect to enter into future
R&D research partnerships to incorporate SonoPrep technology into the
development of novel therapeutic and prophylactic vaccines."
Dr. Davison concluded, "The selling effort and sales cycle required for
adoption of SonoPrep and procedure trays for topical lidocaine anesthesia in
pediatric hospitals are more extensive than our original expectations.
Nevertheless, utilization at adopting hospitals is encouraging. While we
avoided significant selling costs by entering this market through independent
distributors, we learned that successful evaluations require a concerted
direct sales effort. We are currently reevaluating our distribution strategy
and are exploring alternative sales and marketing methods."
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.
Investor Relations Contact:
Sean Moran, Chief Financial Officer
508-530-0334
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 benefits and efficacy
of the SonoPrep device in connection with diagnostics, vaccine delivery,
glucose monitoring and transdermal drug delivery, the expected timing, terms
and benefits of the development agreement with Bayer, the expected market
opportunities, clinical study and product evaluation results, 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 form strategic partnerships and commercialize additional products,
including for the hospital intensive care unit and for vaccine delivery, the
expected benefits of our current and expected strategic partnerships, and
Sontra's business, research, product development, regulatory approval,
marketing and distribution plans and strategies. 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: our technology is new and we
may experience adverse results in research collaborations, product
development, clinical trials, product evaluations, commercialization efforts,
product distribution and market acceptance; the SonoPrep device may not prove
effective in connection with diagnostics, vaccine delivery, glucose monitoring
and/or transdermal drug delivery; markets for our products may develop slower
than expected, or not at all; our sales cycle is lengthy and we are still
developing sales and marketing strategies which may or may not prove
effective; difficulties 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; 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 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 Nine Months Ended
September 30, September 30,
2005 2004 2005 2004
Product revenue $20,615 $12,254 $169,018 $14,754
Cost of product
revenue 149,209 5,523 246,068 6,324
Gross (loss) profit (128,594) 6,731 (77,050) 8,430
Operating Expenses:
Research and
development 998,026 726,261 2,943,821 2,064,785
Selling, general
and administrative 427,564 598,265 1,681,341 1,691,961
Total operating
expenses 1,425,590 1,324,526 4,625,162 3,756,746
Loss from
operations (1,554,184) (1,317,795) (4,702,212) (3,748,316)
Interest income 50,670 17,503 163,151 49,260
Interest expense (5,804) - (12,809) -
Net loss (1,509,318) (1,300,292) (4,551,870) (3,699,056)
Accretion of dividend
and beneficial conversion feature
on Series A
Convertible Preferred
Stock (1,479) (1,479) (4,389) (412,452)
Net loss applicable
to common
stockholders $(1,510,797) $(1,301,771) $(4,556,259) $(4,111,508)
Net loss per common
share, basic
and diluted $(0.07) $(0.07) $(0.21) $(0.26)
Basic and diluted
weighted average
common shares
outstanding 22,233,964 18,339,560 22,186,347 15,741,981
SONTRA MEDICAL CORPORATION
Consolidated Balance Sheets
As of
September 30, December 31,
2005 2004
(Unaudited)
ASSETS
Current Assets:
Cash and cash equivalents $781,747 $2,565,244
Short term investments 4,500,000 6,950,000
Accounts receivable 4,887 16,821
Legal settlement receivable - 250,000
Inventory, net of reserve for
obsolescence 59,408 152,642
Prepaid expenses and other
current assets 91,693 69,492
Total current assets 5,437,735 10,004,199
Property and Equipment, at cost
Computer equipment 241,323 206,970
Office and laboratory equipment 593,576 492,377
Furniture and fixtures 14,288 14,288
Manufacturing equipment 197,888 182,210
Leasehold improvements 177,768 174,698
1,224,843 1,070,543
Less-Accumulated depreciation
and amortization (861,617) (655,242)
Net property and equipment 363,226 415,301
Other Assets:
Restricted cash 29,248 38,997
Other assets 149,741 2,000
Total Other Assets 178,989 40,997
Total assets $5,979,950 $10,460,497
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable $227,406 $358,530
Current portion of note payable 56,889 -
Accrued expenses 388,651 759,051
Total current liabilities 672,946 1,117,581
Note payable, net of current portion 158,375 -
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, 2005
and December 31, 2004
(preference in liquidation of
$74,813) 74,813 76,291
Common stock, $0.01 par value,
authorized 60,000,000 shares,
issued and outstanding
22,243,674 shares at September
30, 2005 and 21,935,732 shares
at December 31, 2004 222,437 219,358
Additional paid-in capital 32,827,532 32,674,740
Deferred stock-based
compensation (41,722) (244,912)
Accumulated deficit (27,934,431) (23,382,561)
Total stockholders' equity 5,148,629 9,342,916
Total liabilities and
stockholders' equity $5,979,950 $10,460,497
SOURCE Sontra Medical Corporation
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Related links:
http://www.sontra.com
CONTACT:
Sean Moran, Chief Financial Officer of Sontra
Medical Corporation, +1-508-530-0334
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