Exhibit
99.3
| |
IMMEDIATE
RELEASE
CONTACTS:
Brent
Larson,
Vice
President / CFO
614
793 7500 x133
|
March
8, 2007
Tim
Ryan,
The
Trout Group
646.378.3924
|
NEOPROBE
RELEASES TEXT OF 2007 LETTER TO SHAREHOLDERS
DUBLIN,
OHIO - March 8, 2007 --Neoprobe Corporation (OTCBB: NEOP) a diversified
developer of innovative oncology diagnostic and treatment products and
cardiovascular surgical and diagnostic products today released the text of
its
annual Letter to Stockholders from Neoprobe Chairman Dr. Julius R. Krevans
and
President and CEO David C. Bupp.
The
letter highlights Neoprobe’s business and financial activities in 2006 and early
2007 and outlines planned business initiatives for the remainder of 2007. The
text of the stockholder letter follows.
Dear
Fellow Stockholders,
This
past
year was an exciting and a challenging one for Neoprobe Corporation as we
strived to achieve our commercialization and development objectives and to
overcome the developmental and regulatory hurdles associated with our biomedical
products. Despite the challenges we faced, we made steady progress in all
aspects of our business strategy. In addition, our progress sets the stage
for
development advancements that we believe will provide significant milestone
achievements in 2007. We continue to execute a two-pronged commercial strategy
comprised of building on a solid foundation of medical devices while we develop
a platform of recurring revenue products led by Lymphoseek®.
During
2006, key commercial and development milestones were achieved in both
areas.
Our
2006
loss from operations decreased from 2005 despite our continued investment in
research and development activities associated with our biomedical product
initiatives. Margin contribution from our medical device businesses continued
to
be strong and to cover a significant portion of our public company corporate
overhead costs. This allowed us to devote our financial resources to the
development of the technology platforms that we expect to provide future
incremental returns. Our total operating loss for the year was $4.7 million
and
included $1.5 million in non-cash charges.
Neoprobe’s
core gamma detection device businesses continued to perform well in 2006. Our
neo2000®
system
continues to be recognized as the market leader among gamma detection devices.
In 2006, we took steps to refresh the brand with the introduction at the October
2006 meeting of the American College of Surgeons (ACS) of the first wireless
probes based upon Bluetooth®
technology. In addition, the new Bluetooth probes incorporate increased probe
sensitivity, further improving the already superior gamma detection capability
and performance of the neo2000. Demonstrating of the ongoing flexibility of
our
neo2000 system, all models of the neo2000 can be simply and easily upgraded
to
permit the use of the Bluetooth probe. The product was very well received by
surgeons at the ACS meeting and we commenced shipment of the product to our
primary distribution partner before year-end. The Bluetooth probes may lead
to
an increased market share for our gamma detection device products in 2007 and
beyond, and the technology may provide a platform for the introduction of
additional products in the near future.
The
commercialization efforts for our blood flow measurement devices began to
provide some positive results in 2006. In June we announced the completion
of a
marketing and distribution agreement with ESTECH, Inc. for our
Quantix®
line of
blood flow measurement products. The ESTECH agreement provides us with access
to
an established sales and marketing organization in the United States and Europe
that is dedicated to meeting the product needs of cardiovascular and vascular
surgeons. Our agreement with ESTECH, coupled with our Asian distribution
arrangements, provides us with a global sales and marketing network for the
Quantix products. While the training of the ESTECH sales organization continued
through the fourth quarter of 2006, we believe the organization is poised to
deliver improved product sales results in 2007.
NEOPROBE
CORPORATION
ADD
- 2
On
an
overall basis in 2006, revenue from sales and service of our medical devices
increased to $6.1 million or approximately 2% over 2005. This increase was
driven by a 77% increase in sales of our blood flow measurement devices which
increased from $340,000 in 2005 to $604,000 in 2006. The gross margin from
our
medical devices totaled $3.4 million or 57% of sales in 2006. Importantly,
fourth quarter 2006 revenue was $1.9 million, an increase of 32% over comparable
fourth quarter 2005 revenue.
In
2006,
our development expenses totaled $3.8 million, a decrease of 6% over the prior
year. The primary reason for the decrease is that our Lymphoseek development
expenses actually declined in 2006 from 2005 as pre-clinical activities begun
in
2005 wound down and human clinical trials did not commence until the third
quarter of 2006. This decrease, coupled with savings from curtailing our Israeli
operations associated with the Quantix products, offset the increase in device
development costs related to launching the Bluetooth probes and continuing
domestic development activities for the Quantix products. We also continued
to
effectively manage our general and administrative overhead structure in an
increasingly complex business environment for public companies. We closed 2006
with cash and securities of approximately $2.5 million.
In
addition to the improvements in our gamma detection device business and the
initial encouraging efforts to commercialize our blood flow measurement devices,
we advanced the clinical development of our first recurring revenue product,
Lymphoseek, to complement and expand our gamma detection device product
businesses. The following are some of the research and development milestones
achieved in 2006 related to our biomedical and medical device
initiatives:
| § |
Acceptance
by FDA of an extensive portfolio of non-clinical studies to demonstrate
the drug safety of Lymphoseek. The non-clinical studies determined
that no
toxicity issues were observed or associated with the active drug
ingredient of Lymphoseek.
|
| § |
Authorization
from FDA to commence patient enrollment in a multi-center Phase 2
clinical
evaluation of Lymphoseek to demonstrate efficacy and to confirm the
safety
of the product in patients with either melanoma or breast
cancer.
|
| § |
Completion
of commercial manufacturing development activities and product release
validation of final drug product in compliance with current Good
Manufacturing Practices (cGMP) conditions.
|
| § |
Receipt
of the first lot of cGMP-produced final drug product that is being
used in
the Phase 2 clinical study.
|
| § |
Completion
of three cGMP production runs of the active pharmaceutical ingredient
(API) of Lymphoseek. The API will be used in at least two of the
final
drug product manufacturing runs of Lymphoseek to support the filing
of a
new drug application (NDA) for
Lymphoseek.
|
| § |
Commencement
of patient enrollment in a multi-center Phase 2 clinical study of
Lymphoseek. Enrollment was underway at year-end at four of the five
clinical study sites and commenced at the fifth study site in February
2007.
|
NEOPROBE
CORPORATION
ADD
- 3
| § |
Introduction
of a revised blood flow measurement algorithm and updated ultrasound
probes for the measurement of blood flow in cardiac bypass graft
(i.e.,
CABG) applications.
|
| § |
Completion
of development activities associated with Bluetooth wireless versions
of
our gamma detection probe. Introduction of the Bluetooth probes at
the ACS
meeting in October and commencement of commercial delivery to customers
in
December.
|
| § |
Receipt
of regulatory clearance to commence patient enrollment in two Phase
1
clinical studies of Lymphoseek in patients with either prostate or
colon
cancers.
|
With
the
completion and acceptance by FDA of the Phase 2 protocol amendment and related
regulatory submissions, we began during the second quarter of 2006 to seek
institutional review board (IRB) clearances through each of the clinical sites
and we commenced patient enrollment in the Phase 2 trial in the third quarter
of
2006. Obtaining IRB clearances was more time consuming than either the Company
or the clinical investigators had forecast or anticipated, but by early February
2007, IRB clearances had been obtained at all of the previously designated
Phase
2 clinical sites. Earlier in March, we reported positive preliminary results
from the first group of patients in the Phase 2 trial. Lymphoseek identified
lymphatic tissue in over 97 % of the treated and evaluable patients. We expect
to have complete results from the second stage of the Phase 2 trial during
the
summer of 2007.
As
we
work to complete the Phase 2 study and to prepare for the initiation of the
Phase 3 studies to support the marketing registration of Lymphoseek in the
United States, we are continuing our discussions with the regulatory agencies
in
Europe to determine the best pathway to seek marketing clearance in the European
Union. As a result of those discussions, it is our intention to pursue marketing
clearance for Lymphoseek through the centralized regulatory authority for the
European Union, the EMEA, in London. We intend to review with the EMEA the
Phase
3 protocol design that will first be discussed with FDA with the intention
of
including European sites in the Phase 3 studies.
Efforts
to develop the Phase 3 protocols and to prepare the submissions to FDA to seek
their approval of the Phase 3 protocol design are substantially underway and
we
hope to meet with FDA during the first half of 2007 to discuss and finalize
the
protocol designs. In addition, we intend to meet with prospective Phase 3
investigators at the upcoming meeting of the Society of Surgical Oncology in
March. Further, we intend to expand by a significant number the Phase 3
investigational sites to accelerate patient enrollment and to commence the
IRB
review and approval process at the earliest opportunity. We believe that the
lessons we have learned during the conduct of the Phase 2 trial will prove
invaluable in helping us achieve our goals and timelines related to the Phase
3
trial.
We
also
received FDA clearance in early 2007 to commence patient enrollment in two
additional Phase 1 clinical studies using Lymphoseek. The two studies involve
patients with either prostate or colon cancers. The studies are being supported
with research grants from the National Cancer Institute but are being performed
under Neoprobe’s Lymphoseek IND and with drug product supplied by Neoprobe.
Activities in 2006 and early 2007 have begun to provide tangible results from
all of the efforts that our personnel, our collaborators and our suppliers
have
made in the development of Lymphoseek.
Although
our 2006 development efforts were focused on Lymphoseek, we did not ignore
activities associated with our other drug research program, RIGScan®
CR. We
completed a submission concerning the design of a new Phase 3 clinical study
to
be conducted in patients with primary colorectal cancer. Our submission included
a proposed clinical trial design with objectives to demonstrate
prognostic/therapeutic endpoints for RIGScan CR. The clinical study includes
both disease-free survival and long-term survival endpoints. FDA invited
Neoprobe to seek a special protocol assessment (SPA) of its RIGScan CR Phase
3
study and Neoprobe intends to seek the SPA review of the complete clinical
package for RIGScan CR in the first half of 2007.
NEOPROBE
CORPORATION
ADD
- 4
What
do
we see in the coming months for Neoprobe Corporation?
| § |
Complete
patient enrollment in the Phase 2 clinical study of Lymphoseek at
cancer
research centers in the United States and report results during the
summer
of 2007.
|
| § |
Initiate
global multi-center Phase 3 clinical studies of Lymphoseek in patients
with either melanoma or breast cancer during the second half of this
year
with the expectation that the results of the Phase 3 studies will
support
the filing of a NDA for the drug in the United States and support
clinical
development and product registration activities in
Europe.
|
| § |
Continue
the clinical evaluation of Lymphoseek in prostate and colon cancers
with
the goal of expanding the application of lymphatic mapping to these
and
other tumor types.
|
| § |
Maintain
the leadership position of our gamma detection device business to
provide
consistent or improved financial contribution as compared to
2006.
|
| § |
Grow
the revenue contribution from our blood flow measurement products
so that
blood flow measurement product revenue will exceed 2006 revenue by
a
significant percentage.
|
| § |
Continue
to support the development activities for RIGScan CR with additional
regulatory submissions, continue preparation for the initiation of
non-clinical and clinical comparability studies, and commence
manufacturing transfer with the assistance of a development partner.
|
In
conclusion, we believe the business and financial prospects and opportunities
for Neoprobe have improved significantly as a result of the activities and
initiatives outlined above. The commercial opportunities afforded by Lymphoseek
will dramatically change the financial prospects for Neoprobe in the coming
years. In addition, the potential of our biomedical product and technology
initiatives may provide significant revenue opportunities to complement our
device and Lymphoseek businesses. All of our products are focused to fulfill
our
mission of developing and commercializing innovative biomedical products that
enhance patient care and improve patient outcome. With your continued assistance
and support, we will work to make Neoprobe an innovative biomedical
company.
Sincerely,
Dr.
Julius R. Krevans, Chairman David
C.
Bupp, President and CEO
NEOPROBE
CORPORATION
ADD
- 5
About
Neoprobe
Neoprobe
is a biomedical company focused on enhancing patient care and improving patient
outcome by meeting the critical intraoperative diagnostic information needs
of
physicians and therapeutic treatment needs of patients. Neoprobe currently
markets the neo2000®
line of
gamma detection systems that are widely used by cancer surgeons and is
commercializing the Quantix®
line of
blood flow measurement products developed by its subsidiary, Cardiosonix Ltd.
In
addition, Neoprobe holds significant interests in the development of related
biomedical systems and radiopharmaceutical agents including
Lymphoseek®
and
RIGScan®
CR.
Neoprobe’s subsidiary, Cira Biosciences, Inc., is also advancing a
patient-specific cellular therapy technology platform called ACT. Neoprobe’s
strategy is to deliver superior growth and shareholder return by maximizing
its
strong position in gamma detection technologies and diversifying into new,
synergistic biomedical markets through continued investment and selective
acquisitions. www.neoprobe.com
Statements
in this news release, which relate to other than strictly historical facts,
such
as statements about the Company’s plans and strategies, expectations for future
financial performance, new and existing products and technologies, anticipated
clinical and regulatory pathways, and markets for the Company’s products are
forward-looking statements The words “believe,” “expect,” “anticipate,”
“estimate,” “project,” and similar expressions identify forward-looking
statements that speak only as of the date hereof. Investors are cautioned that
such statements involve risks and uncertainties that could cause actual results
to differ materially from historical or anticipated results due to many factors
including, but not limited to, the Company’s continuing operating losses,
uncertainty of market acceptance of its products, reliance on third party
manufacturers, accumulated deficit, future capital needs, uncertainty of capital
funding, dependence on limited product line and distribution channels,
competition, limited marketing and manufacturing experience, risks of
development of new products, regulatory risks and other risks detailed in the
Company’s most recent Annual Report on Form 10-KSB and other Securities and
Exchange Commission filings. The Company undertakes no obligation to publicly
update or revise any forward-looking statements.