Filed
Pursuant to Rule 424(B)(5)
Registration
No. 333-168485
PROSPECTUS
SUPPLEMENT
(To
Prospectus Dated August 9, 2010)
Neoprobe
Corporation
3,157,896
Shares of Common Stock
Series
CC Warrants to Purchase 1,578,948 Shares of Common Stock
Series
DD Warrants to Purchase 1,578,948 Shares of Common Stock
Pursuant
to this prospectus supplement and the accompanying prospectus, we are offering
3,157,896 shares of our common stock, Series CC warrants to purchase up to
1,578,948 shares of common stock (and the 1,578,948 shares of common stock
issuable from time to time upon conversion of the Series CC warrants), and
Series DD warrants to purchase up to 1,578,948 shares of common stock (and the
1,578,948 shares of common stock issuable from time to time upon conversion of
the Series DD warrants) to certain institutional investors, or collectively, the
Initial Purchasers. The purchase price for each share of common stock, and
a warrant to purchase one share of common stock is $1.90 (in the aggregate, half
of the warrants purchased by each Initial Purchasers are Series CC Warrants and
half are Series DD Warrants). The Series CC warrants are exercisable for
one year beginning on the date of issuance and have an exercise price of $2.11
per share. The Series DD warrants are exercisable for two years beginning
on the date of issuance, and have an exercise price of $2.11 per
share.
For a
more detailed description of the Series CC warrants and Series DD warrants, see
the section entitled “Description of the Warrants” beginning on page S-10 of
this prospectus supplement. For a detailed description of our common
stock, see the section entitled “Description of Capital Stock” beginning on page
S-11 of this prospectus supplement.
Rodman
& Renshaw, LLC acted as the sole placement agent on this transaction. The
placement agent is not purchasing or selling any of these securities nor is it
required to sell any specific number or dollar amount of securities, but has
agreed to use its reasonable best efforts to sell the securities offered by this
prospectus supplement.
The
Series CC and Series DD warrants will not be listed on any national securities
exchange. Our common stock is quoted on the OTC Bulletin Board under the
symbol "NEOP." On November 5, 2010, the last reported sale price of our
common stock was $2.14 per share.
Investing
in our common stock involves risks. See "Risk Factors" on page S-8 of this
prospectus supplement. You should read this prospectus supplement, the
accompanying prospectus and the documents incorporated by reference into this
prospectus supplement and the accompanying prospectus carefully before you make
an investment decision.
Neither
the Securities and Exchange Commission nor any other regulatory body has
approved or disapproved of these securities or determined if this prospectus
supplement or the accompanying prospectus is truthful or complete. Any
representation to the contrary is a criminal offense.
|
|
Shares of
Common Stock
and Warrant
|
|
|
Per Share of
Common Stock
and Warrant(1)
|
|
|
Total
|
|
Offering
price per share of common stock and warrant
|
|
|
3,157,896 |
|
|
$ |
1.90 |
|
|
$
|
6,000,002 |
|
Placement
Agent Fees(2)
|
|
|
|
|
|
$ |
0.133 |
|
|
$ |
420,000 |
|
Total
Proceeds to Us Before Other Expenses(3)
|
|
|
|
|
|
$ |
1.767 |
|
|
$ |
5,580,002 |
|
(1)
|
Table
excludes shares of common stock issuable upon exercise of the Series CC
and Series DD warrants offered
hereby.
|
(2)
|
A
fee equal to 7% of the aggregate proceeds raised in this offering will be
payable to the placement agent. In
addition to the placement agent fees, the placement agent will receive
warrants to purchase up to 157,895 shares of common stock pursuant to this
prospectus supplement. Please see the “Plan of
Distribution” on page S-12 for
further description of this
arrangement.
|
(3)
|
We
estimate the total expenses of this offering, excluding the placement
agent's fees, will be approximately
$80,000.
|
Delivery
of the common stock and Series CC and Series DD warrants to the Initial
Purchasers will be made on or about November 10, 2010.
Rodman and Renshaw,
LLC
The date
of this prospectus supplement is November 7, 2010.
TABLE
OF CONTENTS
|
|
Page
|
Prospectus
Supplement Dated November 7, 2010
|
|
|
About
this Prospectus Supplement
|
|
S-ii
|
Prospectus
Supplement Summary
|
|
S-1
|
The
Offering
|
|
S-7
|
Risk
Factors
|
|
S-8
|
Forward-Looking
Statements
|
|
S-8
|
Use
of Proceeds
|
|
S-8
|
Dividend
Policy
|
|
S-9
|
Capitalization
|
|
S-9
|
Dilution
|
|
S-9
|
Description
of Warrants
|
|
S-10
|
Description
of Capital Stock
|
|
S-11
|
Plan
of Distribution
|
|
S-12
|
Certain
U.S. Federal Income Tax Consideration
|
|
S-14
|
Legal
Matters
|
|
S-14
|
Where
You Can Find More Information
|
|
S-14
|
Incorporation
of Certain Information by Reference
|
|
S-14
|
|
|
|
Prospectus
Dated August 9, 2010
|
|
|
About
This Prospectus
|
|
2
|
About
Neoprobe Corporation
|
|
2
|
Risk
Factors
|
|
3
|
Special
Note Regarding Forward-Looking Statements
|
|
13
|
Capitalization
|
|
14
|
Where
You Can Find More Information and Incorporation by
Reference
|
|
15
|
Use
of Proceeds
|
|
16
|
Description
of Capital Stock
|
|
16
|
Description
of Warrants
|
|
17
|
Description
of Units
|
|
18
|
Anti-Takeover
Charter Provisions and Laws
|
|
18
|
Selling
Stockholders
|
|
20
|
Plan
of Distribution
|
|
21
|
Legal
Matters
|
|
23
|
Experts
|
|
23
|
ABOUT
THIS PROSPECTUS SUPPLEMENT
You should rely only on the information
incorporated by reference or provided in this prospectus supplement and the
accompanying prospectus, or to which we have referred you. We have not
authorized anyone to provide you with different information. If anyone provides
you with different or inconsistent information, you should not rely on it. This
prospectus supplement and the accompanying prospectus do not constitute an offer
to sell, or a solicitation of an offer to purchase, the securities offered by
this prospectus supplement and the accompanying prospectus in any jurisdiction
where it is unlawful to make such offer or solicitation. You should not assume
that the information contained in this prospectus supplement or the accompanying
prospectus, or any document incorporated by reference in this prospectus
supplement or the accompanying prospectus, is accurate as of any date other than
the date on the front cover of the applicable document. Neither the delivery of
this prospectus supplement nor any distribution of securities pursuant to this
prospectus supplement shall, under any circumstances, create any implication
that there has been no change in the information set forth or incorporated by
reference into this prospectus supplement or in our affairs since the date of
this prospectus supplement. Our business, financial condition, results of
operations and prospects may have changed since that date.
This document is in two parts. The
first part is the prospectus supplement, which adds to and updates information
contained in the accompanying prospectus. The second part is the accompanying
prospectus, which provides more general information, some of which may not apply
to this offering. Generally, when we refer to this prospectus, we are referring
to both parts of this document combined. To the extent there is a conflict
between the information contained in this prospectus supplement, on the one
hand, and the information contained in the accompanying prospectus, on the other
hand, you should rely on the information in this prospectus
supplement.
Before purchasing any securities, you
should carefully read both this prospectus supplement and the accompanying
prospectus, together with the additional information described under the
heading, "Where You Can Find More Information," in this prospectus
supplement.
Unless the context otherwise requires,
references in this prospectus supplement to "we", "us," "our" and “Neoprobe”
refer to Neoprobe Corporation and its subsidiaries.
PROSPECTUS
SUPPLEMENT SUMMARY
This summary highlights information
contained elsewhere or incorporated by reference in this prospectus supplement
and the accompanying prospectus. This summary does not contain all of the
information that you should consider before deciding to invest in our common
stock. You should read this entire prospectus supplement and the accompanying
prospectus carefully, including the "Risk Factors" section and our consolidated
financial statements and the related notes and the other documents incorporated
by reference in the accompanying prospectus.
Neoprobe
Corporation
Neoprobe Corporation is a biomedical
technology company that provides innovative surgical and diagnostic oncology
products that enhance patient care and improve patient outcome. We currently
market a line of medical devices, our neoprobe® GDS gamma detection systems,
that are used in a cancer staging procedure called intraoperative lymphatic
mapping. In addition to our medical device products, we have two
radiopharmaceutical products, Lymphoseek® and RIGScanTM CR, in advanced phases
of clinical development. We are also exploring the development of our activated
cellular therapy (ACT) technology for patient-specific disease treatment through
our majority-owned subsidiary, Cira Biosciences, Inc. (Cira Bio).
Product
Line Overview
We believe Neoprobe's prospects
continue to be bright as we accomplish developmental milestones in our key
growth areas, especially related to our Lymphoseek initiative. Our gamma
detection device line continues to provide a strong revenue base. Revenue
from our gamma detection device product line for the first nine months of 2010
has exceeded our original expectations, and while we expect overall revenue from
our gamma detection device products to continue to be strong for 2010 as a
whole, we expect revenue from this line during the fourth quarter of 2010 to be
relatively consistent with the fourth quarter of 2009. We expect to
continue to incur modest development expenses to support our gamma detection
device product line as well as we work with our marketing partners to expand our
product offerings in the gamma detection device arena. Our primary
development efforts over the last few years have been focused on our oncology
drug development initiatives, Lymphoseek and RIGScan CR. We continue
to make progress with both initiatives; however, neither Lymphoseek nor RIGScan
CR is anticipated to generate any significant revenue for us during
2010.
In August 2009, our Board of Directors
decided to discontinue operations of Cardiosonix and to attempt to divest our
Cardiosonix subsidiary. This decision was based on the determination that the
blood flow measurement device segment was no longer considered a strategic
initiative of the Company, due in large part to positive events in our other
development initiatives. Until a sale is completed, we expect to continue to
generate modest revenues and incur minimal expenses related to our blood flow
measurement device business.
Our efforts thus far in 2010 have
resulted in the following milestone achievements:
|
·
|
Completion
of a successful meeting with the United States Food and Drug
Administration (FDA) to review the Phase 3 (NEO3-05) clinical study
results and discuss development plans to support a New Drug Application
(NDA) submission for Lymphoseek as a lymphatic tissue tracing
agent;
|
|
·
|
Completion
of successful pre-NDA dialogue with FDA on Lymphoseek pre-clinical
data;
|
|
·
|
Completion
of successful pre-NDA dialogue with FDA on Lymphoseek chemistry,
manufacturing and control data;
|
S-1
|
·
|
Initiation
of a third Lymphoseek Phase 3 clinical study in subjects with breast
cancer or melanoma (NEO3-09) to support filing of the NDA with the
potential to expand Lymphoseek's product
labeling;
|
|
·
|
Validation
of the first lot of commercial drug product of Lymphoseek that will be
used for the commercial launch of the product in the United States upon
NDA clearance;
|
|
·
|
Election
of two new directors to Neoprobe’s Board, bringing significant drug
development and medical product industry
expertise;
|
|
·
|
Completion
of exchange transactions that effectively converted all of the Company’s
outstanding debt to equity;
|
|
·
|
Were
awarded grants of over $1.2 million to support Lymphoseek development
through non-dilutive funding;
|
|
·
|
Filed
a shelf registration on Form S-3 to allow the Company to raise capital as
necessary to provide us with additional financial planning flexibility and
to support the diversification of our share ownership to new
institutions;
|
|
·
|
Completion
of a pre-NDA meeting for Lymphoseek clarifying the regulatory pathway for
Lymphoseek approval; and
|
|
·
|
Filed
a complete response to the open biologic license application (BLA) for
RIGScan CR.
|
Our operating expenses during the first
nine months of 2010 were focused primarily on support of Lymphoseek product
development and on efforts to re-qualify the manufacturing process for our
RIGScan CR product initiative. Our drug-related development expenses for
the first nine months of 2010 have been considerably higher than 2009 as we
prepared for the planned filing of a NDA for Lymphoseek and as we continue the
other clinical evaluations of Lymphoseek to support post-marketing amendments to
the NDA.
Lymphoseek
During 2008, we initiated patient
enrollment in a Phase 3 clinical study in subjects with either breast cancer or
melanoma (NEO3-05). In March 2009, we announced that this study had
reached the accrual of 203 lymph nodes, the study’s primary accrual
objective. The NEO3-05 Phase 3 clinical study was an open label trial of
node-negative subjects with either breast cancer or melanoma. It was
designed to evaluate the safety and the accuracy of Lymphoseek while identifying
the lymph nodes draining from the subject’s tumor site. To demonstrate the
accuracy of Lymphoseek, each subject consenting to participate in the study was
injected in proximity to the tumor with Lymphoseek and one of the vital blue
dyes that are commonly used in lymphatic mapping procedures. The primary
efficacy objective of the study was to identify lymph nodes that contained the
vital blue dye and to demonstrate a statistically acceptable concordance rate
between the identification of lymph nodes with the vital blue dye and
Lymphoseek. To be successful, the study needed to achieve a statistical
p-value of at least 0.05. In addition, the secondary endpoint of the study
was to pathologically examine lymph nodes identified by either the vital blue
dyes or Lymphoseek to determine if cancer was present in the lymph
nodes.
In June 2009, we initiated a Phase 3
clinical trial to be conducted in subjects with head and neck squamous cell
carcinoma (NEO3-06). The NEO3-06 clinical study was designed to expand the
potential labeling for Lymphoseek as a sentinel lymph node targeting agent after
the initial marketing clearance for the product. Our discussions with FDA
and the European Medicinal Evaluation Agency (EMEA) have also suggested that the
NEO3-06 clinical trial will further support the use of Lymphoseek in sentinel
lymph node biopsy procedures. We believe the outcome of the trial will be
beneficial to the marketing and commercial adoption of Lymphoseek in the U.S.
and European Union (EU). Based on the discussion with FDA regarding
NEO3-05 in March 2010, we expanded the scope of NEO3-06 and we now plan to have
approximately 20 participating institutions in the NEO3-06 clinical trial.
Subject recruitment and enrollment is actively underway at a number of
institutions and the trial protocol is currently under review at several other
institutions. The accrual rate for trials of this nature is highly
dependent on the timing of institutional review board approvals of the NEO3-06
protocol. Our experience in the NEO3-05 trial has shown that this process
may be lengthening due to risk management concerns on the part of hospitals
participating in clinical trials, as well as other factors.
In March
2010, Neoprobe met with FDA to review the clinical outcomes of NEO3-05.
The meeting included a review of the efficacy and safety results of the NEO3-05
clinical study and Neoprobe’s plans for the submission of a NDA for Lymphoseek
based on the results of NEO3-05 and other previously completed clinical
studies. During the meeting, Neoprobe provided FDA with the clinical
results of the protocol-compliant clinical sites that participated in the
NEO3-05 clinical study that contributed 136 intent-to-treat subjects who
provided 215 lymph nodes containing the vital blue dye. 210 of the vital
blue dye positive lymph nodes contained Lymphoseek for an overall concordance
rate of 98%, achieving a very high level of statistical correlation (p-value =
0.0001) for the primary endpoint of the clinical study. Prior to the
meeting, FDA requested that Neoprobe conduct a “reverse concordance” assessment
of the clinical study where Lymphoseek might identify lymph nodes missed by the
vital blue dyes. This assessment showed that Lymphoseek was able to
identify 85 additional lymph nodes that did not contain the vital blue dye, and
18% of these nodes were found by pathology to contain cancer. There were
no significant reported safety events related to Lymphoseek. FDA indicated
that the clinical data from the NEO3-05 clinical study and other completed
clinical evaluations of Lymphoseek would be supportive of a NDA submission for
Lymphoseek. FDA also encouraged Neoprobe to request a series of
pre-NDA meetings to review the non-clinical and chemistry, manufacturing and
control (CMC) components of the NDA prior to its formal submission.
Neoprobe completed successful non-clinical and CMC pre-NDA reviews with FDA
during the second quarter of 2010.
In July 2010, Neoprobe initiated
enrollment in another Phase 3 clinical evaluation of Lymphoseek in subjects with
either breast cancer or melanoma (NEO3-09). This trial was originally
intended as a supplement to the primary NDA for Lymphoseek for safety evaluation
purposes and to support expanded product labeling claims. NEO3-09 is
currently enrolling patients at eight study sites across the U.S. Neoprobe
expects this study to be completed in the first quarter of 2011.
In October 2010, Neoprobe met with FDA
for a pre-NDA assessment for Lymphoseek. As a result of the pre-NDA
assessment, FDA requested that data from both the completed NEO3-05 study and
the NEO3-09 study currently in progress be included in the Company’s primary NDA
for Lymphoseek rather than submitting the NEO3-09 study data as a planned major
amendment to the ongoing NDA review. The pre-NDA assessment resulted in no
modification to the NEO3-09 trial design or endpoints or to any of the other
previously agreed-to clinical or regulatory components of the Lymphoseek
NDA. As such, NEO3-09 will now be one of two adequate and well-controlled
trials included in the primary NDA submission for a first-cycle
review.
The Lymphoseek NDA submission will be
based on the clinical results of NEO3-05, NEO3-09, and other already completed
clinical evaluations of Lymphoseek. The request for the total data package
from two clinical trials is consistent with FDA’s ongoing initiative to push for
more complete primary submissions and to limit major amendments made to
NDAs. This ongoing initiative to shorten drug review cycle times was
re-emphasized by FDA’s Office of New Drug Development in late 2009 and enables
more successful first-cycle reviews which ultimately shortens overall drug
approval timelines. We believe the earlier than originally planned
inclusion of the NEO3-09 study data may support stronger product labeling as an
outcome of a first-cycle review of the Lymphoseek NDA and may also positively
impact market adoption.
We plan to use the safety and efficacy
results from the Phase 3 clinical evaluations of Lymphoseek, which will include
sites in the EU, to support the drug registration application process in the EU
as well as to amend the filing in the U.S. for expanded product labeling.
Neoprobe expects to submit the NDA for Lymphoseek during the first half of
2011. Depending on the timing of the final pre-NDA meeting with FDA and
the outcome of the FDA regulatory review cycle, we believe that Lymphoseek could
be commercialized in early 2012. We cannot assure you, however, that this
product will achieve regulatory approval, or if approved, that it will achieve
market acceptance.
S-3
RIGScan
CR
Over the past few years, we have also
made progress in advancing our RIGScan CR development program while incurring
minimal research expenses. Our RIGS® technology, which had been
essentially inactive since failing to gain approval following our original
license application in 1997, has been the subject of renewed interest due
primarily to the analysis of survival data related to patients who participated
in the original Phase 3 clinical studies that were completed in 1996.
During 2008, we submitted and received approval from EMEA for a plan to
continue the clinical development for RIGScan CR. The clinical protocol we
submitted to EMEA involves approximately 400 patients in a randomized trial of
patients with colorectal cancer. The participants in the trial would be
randomized to either a control or RIGS treatment arm. Patients randomized
to the RIGS arm would have their disease status evaluated at the end of their
cancer surgery to determine the presence or absence of RIGS-positive
tissue. Patients in both randomized arms would be followed to determine if
patients with RIGS-positive status have a lower overall survival rate and/or a
higher occurrence of disease recurrence. The hypothesis for the trial is
based upon the data from the earlier NEO2-13 and NEO2-14 trial
results.
Our desire has been, and continues to
be, to develop a clinical development plan which is harmonized between the U.S.
and the EU. To that end, during December 2009 we submitted an
investigational new drug (IND) amendment to FDA which included the design of a
proposed Phase 3 clinical trial of RIGScan CR. The IND amendment included
a Special Protocol Assessment (SPA) request in accordance with the Prescription
Drug User Fee Act of 1992 and current regulatory guidelines, and a commitment to
register on the clinicaltrials.gov website following discussions with FDA
regarding the SPA. Since filing the IND amendment and SPA request, we have
determined that due to differences in the current manufacturing process from the
process used in the 1990’s, a further amendment to the IND should be filed
addressing the differences. In addition, in October 2010, we filed a
response letter to FDA related to the Agency’s complete response letter to the
open BLA from 1997. The review responsibility for the RIGS BLA was
recently transferred from the Center for Biologics Evaluation and Research
(CBER) to the Division of Medical Imaging Products in the Center for Drug
Evaluation and Research (CDER) at FDA. The submission of the BLA response
letter is the first of several near-term activities that Neoprobe intends to
complete with FDA to reactivate the development of the RIGS technology. We
intend to file a new IND request for the biologic component of the RIGS
technology. The IND request will be accompanied by a synopsis of a revised
proposed Phase 3 clinical trial design. Once FDA has assigned a new IND,
we will file the complete protocol for FDA evaluation under the provisions of a
SPA. A SPA review of the prospective protocol is expected to provide a
clear development pathway for RIGS in 2011. As a result, we do not expect
to receive feedback from FDA on a RIGS SPA request until sometime in the first
quarter of 2011.
The Phase 3 clinical study as currently
envisioned would be a randomized clinical study that would evaluate the ability
of RIGScan CR to identify tumor-associated tissue in a group of patients as
compared to a group of patients provided with traditional surgical care. Based
on our current statistical analysis, we now believe the sample size for the
proposed Phase 3 clinical study would be approximately 300 patients including
both the RIGScan CR and traditional treatment groups. The primary endpoint of
the trial as proposed is the assessment of the diagnostic ability of RIGScan CR
to identify tumor-associated tissue, with a secondary endpoint of the change of
the treatment paradigm of the RIGScan CR treated patients compared to patients
treated with conventional treatment modalities.
It should also be noted that the
RIGScan CR biologic drug has not been produced for several years. We are
in the process of performing drug characterization work to ensure the drug cell
line is still viable and submit this data to EMEA and possibly FDA for their
evaluation in connection with preparations to restart pivotal clinical
trials. During the third quarter of 2009, we announced that we had
executed a Biopharmaceutical Development and Supply Agreement with Laureate
Pharma, Inc. This agreement will support the initial evaluation of the
viability of the CC49 master working cell bank as well as the initial steps in
re-validating the commercial production process for the biologic agent used in
RIGScan CR. Laureate has made progress in the re-validation of the
manufacturing process and has completed preliminary biologic characterization
activities. They are expected to provide Neoprobe with GMP-produced
material to support non-clinical and clinical evaluation within the next few
months. In addition, we will need to re-establish radiolabeling
capabilities for the CC49 antibody in order to meet the regulatory needs for the
RIGScan CR product. We have also begun discussions with parties capable of
supporting such activities.
S-4
We
continue to believe it will be necessary for us to identify a development
partner or an alternative funding source in order to prepare for and fund the
pivotal clinical testing that will be necessary to gain marketing clearance for
RIGScan CR. In the past, we have engaged in discussions with various
parties regarding such a partnership. We believe the recently clarified
regulatory pathway approved by EMEA is very valuable, but we believe clarifying
the regulatory pathway in the U.S. is important for us and our potential
partners in assessing the full potential for RIGScan CR. However, even if
we are able to make such arrangements on satisfactory terms, we believe that the
time required for continued development, regulatory approval and
commercialization of a RIGS product would likely be a minimum of five years
before we receive any significant product-related royalties or revenues.
We cannot assure you that we will be able to complete definitive agreements with
a development partner or obtain financing to fund development of the RIGS
technology and do not know if such arrangements could be obtained on a timely
basis on terms acceptable to us, or at all. We also cannot assure you that
FDA or EMEA will clear our RIGS products for marketing or that any such products
will be successfully introduced or achieve market acceptance.
Activated
Cellular Therapy
In 2005, we formed a new subsidiary,
Cira Bio, to explore the development of ACT. Neoprobe owns approximately
90% of the outstanding shares of Cira Bio with the remaining shares being held
by the principals of a private holding company, Cira LLC. In conjunction
with the formation of Cira Bio, an amended technology license agreement also was
executed with The Ohio State University, from whom both Neoprobe and Cira LLC
had originally licensed or optioned the various cellular therapy
technologies. As a result of the cross-license agreements, Cira Bio has
the exclusive development and commercialization rights to three issued U.S.
patents that cover the oncology and autoimmune applications of its
technology. In addition, Cira Bio has exclusive licenses to several
pending patent applications. We hope to identify a funding source to
continue Cira Bio’s development efforts. If we are successful in
identifying a funding source, we expect that any funding would likely be
accomplished by an investment directly into Cira Bio, so that the funds raised
would not dilute current Neoprobe shareholders. Obtaining this funding
would likely dilute Neoprobe’s ownership interest in Cira Bio; however, we
believe that moving forward such a promising technology will only yield positive
results for the Neoprobe stockholders and the patients who could benefit from
these treatments. We have been encouraged by recent media speculation
regarding the potential connection of a retrovirus with chronic fatigue syndrome
and the potential use of ACT to develop a treatment, which may stimulate some
interest in our ACT platform. However, we do not know if we will be
successful in obtaining funding on terms acceptable to us, or at all. In
the event we fail to obtain financing for Cira Bio, the technology rights for
the oncology applications of ACT may revert back to Neoprobe and the technology
rights for the viral and autoimmune applications may revert back to Cira LLC
upon notice by either party.
We expect our gamma detection device
products to contribute a net profit in 2010 for that line of business, excluding
general and administrative costs, interest and other financing-related
charges. Our overall operating results for 2010 will also be greatly
affected by the increased level of development activity we have conducted in
2010 to support our radiopharmaceutical products. Primarily as a result of
the significant development costs we expect to incur related to the continued
clinical development of Lymphoseek and RIGScan CR, we do not expect to achieve
overall operating profitability during 2010. We cannot assure you that our
current or potential new products will be successfully commercialized, that we
will achieve significant product revenues, or that we will achieve or be able to
sustain profitability in the future.
S-5
Corporate
Information
We were originally incorporated in Ohio
in 1983 and reincorporated in Delaware in 1988. Our executive offices are
located at 425 Metro Place North, Suite 300, Dublin, Ohio 43017. Our telephone
number is (614) 793-7500. Our corporate website is www.neoprobe.com. This
reference to our website is a textual reference only. We do not incorporate the
information on our website into this prospectus and you should not consider any
information on, or that can be accessed through, our website as part of this
prospectus.
S-6
THE
OFFERING
The following is a brief summary of
some of the terms of this offering and is qualified in its entirety by reference
to the more detailed information appearing elsewhere in this prospectus
supplement and the accompanying prospectus.
Securities
we are offering
|
|
3,157,896
shares of common stock, Series CC warrants to purchase up to 1,578,948
shares of common stock (and the 1,578,948 shares of common stock issuable
from time to time upon conversion of the Series CC warrants), and Series
DD warrants to purchase up to 1,578,948 shares of common stock (and the
1,578,948 shares of common stock issuable from time to time upon
conversion of the Series DD warrants). The purchase price for
each share of common sock, and a warrant to purchase one share of common
stock is $1.90 (in the aggregate, half of the warrants purchased by each
Initial Purchasers are Series CC Warrants and half are Series DD
Warrants). The shares of common stock and warrants will be
issued separately, but can only be purchased together in this
offering.
|
|
|
|
Description
of the Series CC Warrants and Series DD Warrants
|
|
The
Initial Purchasers will receive a warrant to purchase one share of common
stock for each share of common stock purchased in this offering (in the
aggregate, half of the warrants purchased must be Series CC Warrants and
half must be Series DD Warrants). The Series CC warrants and Series DD
Warrants are each exercisable at an exercise price of $2.11 per share of
common stock. The Series CC Warrants are exercisable for one year after
the date of issuance, and the Series DD Warrants are exercisable fro two
years after the date of issuance. See “Description of
Warrants.”
|
|
|
|
Limitation
on Exercise of Warrants
|
|
No
holder may exercise its warrants to the extent that the exercise would
result in the holder and its affiliates beneficially owning 4.99% or more
of our common stock, provided that a holder may elect to increase the
exercise threshold to 9.99% of our common stock by providing us with 61
days’ prior notice.
|
|
|
|
Use
of proceeds after expenses
|
|
We
intend to use the proceeds to complete the development and
commercialization of Lymphoseek, support the manufacturing process,
clinical testing and development of our RIGScan CR product initiative, and
for general corporate purposes. See “Use of Proceeds” on Page
S-8.
|
|
|
|
OTC
Bulletin Board Symbol
|
|
NEOP
|
RISK
FACTORS
An investment in our common stock
involves a high degree of risk. You should carefully consider the risk factors
contained in our most recently filed periodic reports filed with the SEC,
including our Annual Report on Form 10-K for the year ended
December 31, 2009, as revised or supplemented by our most recent quarterly
report on Form 10-Q, each of which are on file with the SEC and are
incorporated by reference into this prospectus. Before making an investment
decision, you should carefully consider these risks as well as other information
we include or incorporate by reference in this prospectus or included in any
applicable prospectus supplement. Additional risks and uncertainties not
presently known to us or that we deem currently immaterial may also impair our
business, operating results and financial condition and could result in a
complete loss of your investment.
FORWARD-LOOKING
STATEMENTS
This prospectus supplement, the
accompanying prospectus and the information incorporated by reference in these
documents contain forward-looking statements within the meaning of Section 27A
of the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended. We sometimes use words such as
“anticipate,” “believe,” “continue,” “estimate,” “expect,” “intend,” “may,”
“plan,” “potential,” “predict,” “project,” “should,” “will” and similar
expressions, as they relate to us, our management and our industry, to identify
forward-looking statements. Forward-looking statements relate to our
expectations, beliefs, plans, strategies, prospects, future performance,
anticipated trends and other future events. Specifically, this prospectus and
the information incorporated by reference in this prospectus contain
forward-looking statements relating to, among other things:
|
·
|
our
primary operating costs and
expenses;
|
|
·
|
evaluation
of possible acquisitions of, or investments in business, products and
technologies; and
|
|
·
|
sufficiency
of existing cash to meet operating
requirements.
|
These statements involve known and
unknown risks, uncertainties, and other factors that may cause our or our
industry’s past results, levels of activity, performance, or achievements to be
materially different from any future results, levels of activity, performance,
or achievements expressed or implied by such forward-looking statements. Actual
results may differ materially. Some of the risks, uncertainties and assumptions
that may cause actual results to differ from these forward-looking statements
are described in “Risk Factors” and elsewhere in this prospectus, and may also
be found in an accompanying prospectus supplement and in information
incorporated by reference.
You should read this prospectus, the
documents that we filed as exhibits to the registration statement of which this
prospectus is a part and the documents that we incorporate by reference in this
prospectus completely and with the understanding that our future results may be
materially different from what we expect. We qualify all of our forward-looking
statements by these cautionary statements, and we assume no obligation to update
these forward-looking statements publicly for any reason.
USE
OF PROCEEDS
We estimate that the net proceeds from
this offering will be approximately $5.5 million after deducting the
underwriting discounts and commissions and estimated offering expenses. We
intend to use the net proceeds from this offering to complete the development
and commercialization of Lymphoseek, support the manufacturing process, clinical
testing and development of our RIGScan CR product initiative, and for general
corporate purposes. As a result, our management with have broad discretion
to allocate the net proceeds from this offering.
DIVIDEND
POLICY
We have never declared or paid cash
dividends on our capital stock. We currently intend to retain our future
earnings, if any, for use in our business and therefore do not anticipate paying
cash dividends in the foreseeable future. Payment of future dividends, if any,
will be at the discretion of our board of directors after taking into account
various factors, including our financial condition, operating results, current
and anticipated cash needs and plans for expansion.
CAPITALIZATION
The following table sets forth our
other cash, total liabilities and capitalization as of June 30, 2010, as
follows:
|
·
|
on
an actual basis; and
|
|
·
|
on
an adjusted basis after giving effect to our sale of 3,157,896 shares of
common stock offered hereby at a public offering price of $1.90 per share
and after deducting the underwriting discounts and commission of $0.133
per share and estimated offering
expenses.
|
You should read this table along with
our historical consolidated financial statements and notes and related notes and
the other financial information included and incorporated by reference in this
prospectus supplement and the accompanying prospectus.
|
|
June 30, 2010
Actual (Unaudited)
|
|
|
Adjustments (1)
|
|
|
June 30, 2010
Pro Forma
|
|
|
|
|
|
|
|
|
|
|
|
Cash
|
|
$ |
3,944,782 |
|
|
$ |
5,500,000 |
|
|
$ |
9,444,782 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
5,187,339 |
|
|
|
|
|
|
|
5,187,339 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
stock
|
|
|
11 |
|
|
|
|
|
|
|
11 |
|
Common
stock
|
|
|
82,151 |
|
|
|
3,158 |
|
|
|
85,309 |
|
Additional
paid-in capital
|
|
|
249,007,591 |
|
|
|
5,496,842 |
|
|
|
254,504,433 |
|
Accumulated
deficit
|
|
|
(246,385,404 |
) |
|
|
|
|
|
|
(246,385,404 |
) |
Total
stockholders’ equity
|
|
|
2,704,349 |
|
|
|
|
|
|
|
8,204,349 |
|
Total
capitalization
|
|
$ |
7,891,688 |
|
|
|
|
|
|
$ |
13,391,688 |
|
|
(1)
|
As
a result of issuing 3,157,896 shares of common stock as a result of the
offering but excluding the potential effect of the additional shares
registered but not sold under the Prospectus Supplement to this
Registration Statement as such shares registered are: (1) for a secondary
offering by selling shareholders; or (2) the sale of an undetermined
number and amount of primary
shares.
|
DILUTION
As of June 30, 2010, our unaudited net
tangible book value was $2.6 million, or approximately $0.03 per share. Net
tangible book value is total assets minus the sum of liabilities and intangible
assets. Net tangible book value per share is net tangible book value divided by
the total number of shares of common stock outstanding.
Net tangible book value dilution per
share to new investors represents the difference between the amount per share
paid by purchasers of securities in this offering and the net tangible book
value per share of our common stock immediately after completion of this
offering. For purposes of this calculation, we have allocated the entire
purchase price of the securities to the common stock, and nothing to the
warrants. After giving effect to the sale of 3,157,896 shares of our
common stock and deducting the placement agent commissions and our estimated
offering expenses, our net tangible book value as of June 30, 2010 would have
been $0.10 per share. This amount represents an immediate increase in net
tangible book value of $0.07 per share to existing stockholders and an
immediate dilution in net tangible book value of $1.80 per share to purchasers
of common stock in this offering, as illustrated in the following
table:
Public
offering price per share of common stock
|
|
|
|
|
|
$ |
1.90 |
|
|
|
|
|
|
|
|
|
|
Net
tangible book value per share as of June 30, 2010
|
|
$
|
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase
in net tangible book value per share after giving effect to this
offering
|
|
$ |
0.07
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro
forma net tangible book value per share as of June 30, 2010 after effect
to the offering
|
|
|
|
|
|
$ |
0.10 |
|
|
|
|
|
|
|
|
|
|
Dilution
in net tangible book value per share to new investors
|
|
|
|
|
|
$ |
1.80 |
|
This table assumes no (i) exercise of options
to purchase 5,491,167 shares of common stock at a weighted average exercise
price of $0.44 per share outstanding as of June 30, 2010, (ii) exercise of
warrants to purchase 17,803,333 shares of our common stock at a weighted average
exercise price of $0.48 per share, (iii) issuance of 32,700,000 shares of common
stock upon conversion of 10,000 shares of Series B Convertible Preferred Stock,
(iv) issuance of 3,226,000 shares of common stock upon conversion of 1,000
shares of Series C Convertible Preferred Stock, and (v) issuance of 3,157,896
shares of common stock upon the exercise of warrants to be issued in this
offering, at an exercise price of $2.11 per share. To the extent that
options or warrants are exercised, or shares are issued upon conversion of
convertible preferred stock, there will be further dilution to new
investors.
DESCRIPTION
OF WARRANTS
The
material terms and provisions of the Series CC warrants and Series DD warrants
being offered pursuant to this prospectus supplement and the accompanying
prospectus are summarized below. This summary is subject to, and qualified in
its entirety by, the terms set forth in the Series CC Common Stock Purchase
Warrant and Series DD Common Stock Purchase Warrant, respectively, to be filed
as exhibits to our Current Report on Form 8-K, which we expect to file with the
SEC in connection with this offering.
General
The Series CC warrants are exercisable
for one year beginning on the date of issuance, and the Series DD warrants are
exercisable for two years beginning on the date of issuance. The warrants
will be exercisable, at the option of the holder, upon the surrender of the
warrants to us and the payment in cash of the exercise price of the shares of
common stock being acquired upon exercise of the warrants. However, if at the
time of exercise there is no effective registration statement registering the
issuance of the shares of common stock issuable upon exercise of the warrants to
the holder and all such shares are not then registered for resale by the holder,
the holder may exercise the warrants by means of a “cashless exercise” or “net
exercise.” The warrants will not be listed on any national securities
exchange.
The exercise price per share of common
stock purchasable upon exercise of both the Series CC warrants and the Series DD
warrants is $2.11 per share of common stock being purchased. The exercise price
is subject to appropriate adjustment in the event of stock dividends, stock
splits, reorganizations or similar events affecting our common stock. The
holders of the warrants are entitled to 20 days’ notice before the record date
for certain distributions to holders of our common stock. If certain
“fundamental transactions” occur, such as a merger, consolidation, sale of
substantially all of our assets, tender offer or exchange offer with respect to
our common stock or reclassification of our common stock, the holders of the
warrants will be entitled to receive thereafter in lieu of our common stock, the
consideration (if different from common stock) that the holders of the warrants
would have been entitled to receive upon the occurrence of the “fundamental
transaction” as if the warrant had been exercised immediately before the
“fundamental transaction.” If any holder of common stock is given a choice of
consideration to be received in the “fundamental transaction,” then the holders
of the warrants shall be given the same choice upon the exercise of the warrants
following the “fundamental transaction.”
As of November 5, 2010, other warrants
to purchase approximately 17.9 million shares of common stock are
outstanding.
DESCRIPTION
OF CAPITAL STOCK
The following description of our
capital stock is only a summary and is subject to the provisions of our amended
and restated certificate of incorporation, or certificate of incorporation, and
our amended and restated by-laws, or by-laws, which are included as exhibits to
the registration statement of which this prospectus forms a part, and provisions
of applicable law.
Our articles of incorporation authorize
our board of directors to issue 200,000,000 shares of common stock and 5,000,000
shares of preferred stock. As of November 5, 2010, 82,442,371 shares of
common stock were issued outstanding, and 11,000 shares of preferred stock were
issued and outstanding.
Common
Stock
Dividends
Each share of common stock is entitled
to receive an equal dividend, if one is declared, which is unlikely. We have
never paid dividends on our common stock and do not intend to do so in the
foreseeable future. We intend to retain any future earnings to finance our
growth. See Risk Factors.
Liquidation
If our company is liquidated, any
assets that remain after the creditors are paid, and the owners of preferred
stock receive any liquidation preferences, will be distributed to the owners of
our common stock pro-rata.
Voting
Rights
Each share of our common stock entitles
the owner to one vote. There is no cumulative voting. A simple majority can
elect all of the directors at a given meeting and the minority would not be able
to elect any directors at that meeting.
Preemptive
Rights
Owners of our common stock have no
preemptive rights. We may sell shares of our common stock to third parties
without first offering it to current stockholders.
Redemption
Rights
We do not have the right to buy back
shares of our common stock except in extraordinary transactions such as mergers
and court approved bankruptcy reorganizations. Owners of our common stock do not
ordinarily have the right to require us to buy their common stock. We do not
have a sinking fund to provide assets for any buy back.
Conversion
Rights
Shares of our common stock can not be
converted into any other kind of stock except in extraordinary transactions,
such as mergers and court approved bankruptcy reorganizations.
Preferred
Stock
Our certificate of incorporation
authorizes our board of directors to issue "blank check" preferred stock. The
board of directors may divide this stock into series and set their rights. On
December 26, 2007, the board of directors designated 3,000 shares of preferred
stock as Series A 8% Cumulative Convertible Preferred Stock (Series A Preferred
Stock), which were issued to Montaur on December 5, 2008. On June 22, 2010, the
board of directors designated 10,000 shares of preferred stock as Series B
Convertible Preferred Stock (Series B Preferred Stock), and 1,000 shares of
preferred stock as Series C Convertible Preferred Stock (Series C Preferred
Stock). Also, on June 22, 2010: (1) Montaur surrendered the Amended Series A
Note and all 3,000 shares of Series A Preferred Stock issued to it on December
5, 2008, in exchange for 10,000 shares of Series B Preferred Stock; and (2) we
issued 1,000 shares of Series C Preferred Stock to David C. Bupp, the Company’s
President and Chief Executive Officer, and Cynthia B. Gochoco, both individually
and as co-executors of the Estate of Walter H. Bupp (the Bupp Investors).
Montaur may convert all or any portion of the shares of Series B Preferred Stock
into an aggregate 32,700,000 shares of our common stock, and the Bupp Investors
may convert all or any portion of the shares of Series C Preferred Stock into an
aggregate 3,226,000 shares of our common stock.
The board of directors may, without
prior stockholder approval, issue any of the remaining 4,989,000 shares of
authorized preferred stock with dividend, liquidation, conversion, voting or
other rights which could adversely affect the relative voting power or other
rights of the common stock. Preferred stock could be used as a method of
discouraging, delaying, or preventing a take-over of our Company. If we do issue
preferred stock in the future, it could have a dilutive effect upon the common
stock. See Risk Factors.
PLAN
OF DISTRIBUTION
Rodman & Renshaw, LLC (the
"placement agent") has acted as our sole placement agent in connection with this
offering of 3,157,896 shares of our common stock, Series CC warrants to purchase
up to 1,578,948 shares of common stock (and the 1,578,948 shares of common stock
issuable from time to time upon conversion of the Series CC warrants), and
Series DD warrants to purchase up to 1,578,948 shares of common stock (and the
1,578,948 shares of common stock issuable from time to time upon conversion of
the Series DD warrants). The
purchase price for each share of common stock and a warrant to purchase one
share of common stock is $1.90.
The placement agent will be working
solely on a “reasonable best efforts” basis and is not purchasing or selling any
securities offered by this prospectus supplement or the accompanying prospectus,
nor is it required to arrange for the purchase and sale of any specific number
or dollar amount of securities. Therefore, we may not sell the entire amount of
common stock and warrants offered pursuant to this prospectus
supplement.
We currently anticipate that closing of
the sale of the common stock and warrants will occur on or about November
10, 2010, subject to customary closing conditions. On the closing
date, the following will occur:
|
·
|
We
will receive funds in the amount of the aggregate purchase price of the
common stock and warrants.
|
|
·
|
The
placement agent will receive the placement agent fees in accordance with
the terms of the letter agreement.
|
|
·
|
We
will irrevocably instruct the transfer agent to deliver the shares of
common stock, and we will deliver the warrants, to the Initial
Purchasers.
|
On November 7, 2010, we enter entered
into a letter agreement with the placement agent to serve as exclusive placement
agent for purchasers of our securities for a period of 30 days. Pursuant to the
letter agreement, we will pay the placement agent at closing a cash fee equal to
7% of the aggregate gross proceeds raised in this offering, plus warrants to
purchase shares of common stock in an amount equal to 5% of the aggregate number
of shares of common stock sold in the offering. Assuming all of the common stock
and warrants offered by the prospectus supplement are issued and sold by us, we
will pay the placement agent $0.133 per share, or $420,000 in the aggregate, and
warrants to purchase up to 157,895 shares of common stock. The warrants
issued to the placement agent will have the same terms as the warrants issued to
the Initial Purchasers except that the warrant issued to the placement agent
will have an exercise price of $2.375 per share (125% of the public offering
price) and an expiration date of August 9, 2015 (the five year anniversary of
the effective date of the registration statement).
The following table shows the per share and total fees
we will pay to the placement agent in connection with the sale of our securities
offered pursuant to this prospectus supplement and the accompanying prospectus,
assuming the purchase of all of the securities offered hereby and excluding
proceeds that we may receive upon exercise of the warrants:
|
|
$ |
0.133 |
|
Total Placement Agent Fees
|
|
$ |
420,000 |
|
Because there is no minimum offering
amount required as a condition to closing, the actual total may be less than the
total set forth above.
The estimated offering expenses payable
by us, excluding the placement agency fee, are $80,000, which include legal,
accounting and printing costs, and various other fees associated with
registering the shares of common stock issuable from time to time upon exercise
of the warrants.
We have agreed to indemnify the
placement agent against certain liabilities, including liabilities under the
Securities Act. We may also be required to contribute to payments the placement
agent may be required to make in respect of such liabilities.
The agreement with the placement agent
and the purchase agreement with the Initial Purchasers will be included as
exhibits to a Current Report on Form 8-K that will be filed with the SEC in
connection with this offering.
We are subject to a lock-up agreement
for a period of 30 days following the date of this prospectus supplement.
Pursuant to the lock-up agreement, we have agreed that neither we nor any
subsidiary will, without the prior consent of the Initial Purchasers, issue or
enter into any agreement to issue or announce the issuance or proposed issuance
of any of our common stock or any other of our or our subsidiaries' securities,
including debt, preferred stock, rights, options, warrants or other instruments
that is at any time convertible into or exercisable or exchangeable for, or
otherwise entitles the holder thereof to receive, Common Stock.
In addition, from the date of issuance
until such time as no Purchaser holds any of the Series CC warrants or
Series DD warrants, we are prohibited from effecting or entering into any
agreement to effect any issuance by us or our subsidiaries of our or our
subsidiaries' securities involving a variable rate transaction.
Variable rate transactions mean transactions in which we (i) issue or sell
any debt or equity securities that are convertible into, exchangeable or
exercisable for, or include the right to receive additional shares of our common
stock either (A) at a conversion price, exercise price or exchange rate or other
price that is based upon and/or varies with the trading prices of or quotations
for the shares of our common stock at any time after the initial issuance of
such debt or equity securities, or (B) with a conversion, exercise or exchange
price that is subject to being reset at some future date after the initial
issuance of such debt or equity security (but not including customary
anti-dilution provisions) or upon the occurrence of specified or contingent
events directly or indirectly related to the business of our Company or the
market for our Common Stock, or (ii) enter into any arrangement, including but
not limited to, an equity line of credit, whereby we may sell securities at a
future determined price.
CERTAIN
U.S. FEDERAL INCOME TAX CONSIDERATIONS
All purchasers of common stock and
warrants are advised to consult their own tax advisors regarding the federal,
state, local and foreign tax consequences of the purchase, ownership, or
exercise, as the case may be, and disposition of the common stock and warrants
and the ownership and disposition of shares of common stock issuable upon
exercise of warrants in their particular situations.
LEGAL
MATTERS
Certain legal matters will be passed
upon for us by Porter Wright Morris & Arthur LLP, Columbus,
Ohio.
WHERE
YOU CAN FIND MORE INFORMATION
This prospectus supplement and the
accompanying prospectus are part of the registration statement on Form S-3
we filed with the SEC under the Securities Act of 1933, as amended, and do not
contain all the information set forth in the registration statement. Whenever a
reference is made in this prospectus supplement or the accompanying prospectus
to any of our contracts, agreements or other documents, the reference may not be
complete and you should refer to the exhibits that are a part of the
registration statement or the exhibits to the reports or other documents
incorporated by reference in this prospectus supplement and the accompanying
prospectus for a copy of such contract, agreement or other
document.
Because we are subject to the
information and reporting requirements of the Securities Exchange Act of 1934,
as amended, we file annual, quarterly and special reports, proxy statements and
other information with the SEC. Our SEC filings are available to the public over
the Internet at the SEC's web site at http://www.sec.gov. You may also read and
copy any document we file at the SEC's Public Reference Room at 100 F
Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330
for further information on the operation of the Public Reference
Room.
INCORPORATION
BY REFERENCE
We “incorporate by reference” into this
prospectus the information we file with the Commission (Commission file number
0-26520), which means that we can disclose important information to you by
referring you to those documents. The information incorporated by
reference is an important part of this prospectus. Information that we
file with the Commission after the date of this prospectus will automatically
update this prospectus. We incorporate by reference the documents listed
below, and any filings we make with the Commission under Sections 13(a),
13(c), 14, or 15(d) of the Securities Exchange Act of 1934 after the
initial filing of the registration statement that contains this prospectus
(except for information furnished and not filed with the Commission in a Current
Report on Form 8-K):
|
·
|
our
Annual Report on Form 10-K for the year ended December 31, 2009, filed
with the Commission on March 31,
2010;
|
|
·
|
our
Quarterly Reports on Form 10-Q for the quarterly periods ended March 31,
2010, filed with the Commission on May 14, 2010, and June 30, 2010, filed
with the Commission on August 10,
2010;
|
|
·
|
our
Current Reports on Form 8-K, dated January 11, 2010 (filed January 11,
2010), dated January 26, 2010 (filed January 28, 2010), dated February 24,
2010 (filed February 26, 2010), dated March 11, 2010 (filed March 12,
2010), dated May 26, 2010 (filed May 27, 2010), dated June 22, 2010 (filed
June 28, 2010), dated July 16, 2010 (filed July 20, 2010) and dated
October 6, 2010 (filed October 6, 2010);
and
|
|
·
|
the
description of our common stock which is contained in our Form 8-A filed
with the Commission pursuant to Section 12 of the Securities Exchange Act
of 1934, as amended, as updated in any amendment or report filed for the
purpose of updating such
description.
|
Information furnished by us in Current
Reports on Form 8-K under Items 2.02 and 9.01 is expressly not incorporated by
reference in this prospectus.
We will provide to each person,
including any beneficial owner, to whom a prospectus is delivered, without
charge, upon written or oral request, a copy of any or all of the documents that
are incorporated by reference into this prospectus but not delivered with the
prospectus, including exhibits that are specifically incorporated by reference
into such documents. You may request a copy of these filings at no cost,
by writing to or telephoning us at:
Neoprobe
Corporation
Attn:
Brent L. Larson
425 Metro
Place North
Dublin,
Ohio 43017-1367
(614)
822-2330
PROSPECTUS
NEOPROBE
CORPORATION
$20,000,000
Common
Stock
Common
Stock Warrants
Units
15,000,000
Shares of Common Stock
Offered
by Selling Stockholders
·
|
We
may offer from time to time to sell, separately or together as units: (1)
shares of our common stock; and (2) warrants to purchase our common
stock. The aggregate offering price of shares of common stock and
warrants to purchase common stock sold by us under this prospectus will
not exceed $20,000,000. In addition, this prospectus covers resales of
15,000,000 shares our common stock owned by Platinum-Montaur Life
Sciences, LLC and its transferees, in the circumstances we describe (the
“selling
stockholder”). We will not receive any proceeds from the sale, if
any, of common stock by the selling
stockholder.
|
·
|
This
prospectus provides a general description of the securities we or the
selling stockholders may offer. Each time we or the selling
stockholders sell securities, we will provide specific terms of the
securities offered in a supplement to this prospectus. The
prospectus supplement may also add, update or change information contained
in this prospectus. You should read this prospectus and the
applicable prospectus supplement carefully before you invest in any
securities. This prospectus may not be used to consummate a sale of
securities unless accompanied by the applicable prospectus
supplement.
|
·
|
We
or the selling stockholders will sell these securities directly to
purchasers or through agents on our behalf or through underwriters or
dealers as designated from time to time. If any agents or
underwriters are involved in the sale of any of these securities, the
applicable prospectus supplement will provide the names of the agents or
underwriters and any applicable fees, commissions or
discounts.
|
·
|
The
last reported sale price of our common stock on August 2, 2010 was $2.01
per share.
|
·
|
Trading
symbol: OTC Bulletin Board –
NEOP.
|
Investing
in our securities involves a high degree of risk. Before investing in our
securities, we recommend that you carefully read this entire prospectus,
including the “Risk Factors” section beginning on page 4, any applicable
supplements to this prospectus and the documents we file with the Securities and
Exchange Commission from time to time.
Neither
the Securities and Exchange Commission nor any state securities commission has
approved of anyone’s investment in these securities or determined if this
prospectus is truthful or complete. Any representation to the contrary is
a criminal offense.
Neoprobe
Corporation
425 Metro
Place North, Suite 300
Dublin,
OH 43017-1367
(614)
793-7500
The date
of this prospectus is August 9, 2010
TABLE
OF CONTENTS
|
|
Page
|
About
This Prospectus
|
|
2
|
About
Neoprobe Corporation
|
|
2
|
Risk
Factors
|
|
3
|
Special
Note Regarding Forward-Looking Statements
|
|
13
|
Capitalization
|
|
14
|
Where
You Can Find More Information and Incorporation by
Reference
|
|
15
|
Use
of Proceeds
|
|
16
|
Description
of Capital Stock
|
|
16
|
Description
of Warrants
|
|
17
|
Description
of Units
|
|
18
|
Anti-Takeover
Charter Provisions and Laws
|
|
18
|
Selling
Stockholders
|
|
20
|
Plan
of Distribution
|
|
21
|
Legal
Matters
|
|
23
|
Experts
|
|
23
|
ABOUT
THIS PROSPECTUS
This prospectus is a part of a
registration statement that we filed with the Securities and Exchange
Commission, or the Commission, utilizing a “shelf” registration process.
Under this shelf registration process, we may offer to sell the securities
described in this prospectus in one or more offerings up to a total dollar
amount of $20,000,000. This prospectus also relates to the offer and sale
from time to time of up to 15,000,000 shares of our common stock in one or more
offerings by the selling stockholder identified in this prospectus. This
prospectus provides you with a general description of the securities we or the
selling stockholders may offer. We may add to or modify in a prospectus
supplement any of the information contained in this prospectus or in the
documents that we have incorporated into this prospectus by reference. To the
extent that any statement made in a prospectus supplement conflicts with
statements made in this prospectus, the statements made in the prospectus
supplement will be deemed to modify or supersede those made in this prospectus.
Each time we sell securities under this shelf registration, we will provide a
prospectus supplement that will contain specific information about the terms of
that offering. You should read both this prospectus and any
prospectus supplement, including all documents incorporated herein or therein by
reference, together with additional information described under “Where You Can
Find More Information and Incorporation by Reference.”
We have not authorized any dealer,
salesman or other person to give any information or to make any representation
other than those contained or incorporated by reference in this prospectus and
the accompanying prospectus supplement. You must not rely upon any
information or representation not contained or incorporated by reference in this
prospectus or the accompanying prospectus supplement. This prospectus and
the accompanying prospectus supplement do not constitute an offer to sell or the
solicitation of an offer to buy any securities other than the registered
securities to which they relate, nor does this prospectus and the accompanying
prospectus supplement constitute an offer to sell or the solicitation of an
offer to buy securities in any jurisdiction to any person to whom it is unlawful
to make such offer or solicitation in such jurisdiction. You should not
assume that the information contained in this prospectus and the accompanying
prospectus supplement is accurate on any date subsequent to the date set forth
on the front of the document or that any information we have incorporated by
reference is correct on any date subsequent to the date of the document
incorporated by reference, even though this prospectus and any accompanying
prospectus supplement is delivered or securities are sold on a later
date.
In this prospectus, “we,” “us,” “our”
and “Neoprobe” refer to Neoprobe Corporation and its subsidiaries.
ABOUT
NEOPROBE CORPORATION
Neoprobe Corporation is a biomedical
technology company that provides innovative surgical and diagnostic oncology
products that enhance patient care and improve patient outcome. We
currently market a line of medical devices, our neoprobe® GDS
gamma detection systems, that are used in a cancer staging procedure called
intraoperative lymphatic mapping. In addition to our medical device
products, we have two radiopharmaceutical products, Lymphoseek® and
RIGScanTM CR, in
advanced phases of clinical development. We are also exploring the
development of our activated cellular therapy (ACT) technology for
patient-specific disease treatment through our majority-owned subsidiary, Cira
Biosciences, Inc. (Cira Bio).
We were originally incorporated in Ohio
in 1983 and reincorporated in Delaware in 1988. Our executive offices are
located at 425 Metro Place North, Suite 300, Dublin, Ohio 43017. Our
telephone number is (614) 793-7500. Our corporate website is www.neoprobe.com. This reference
to our website is a textual reference only. We do not incorporate the
information on our website into this prospectus and you should not consider any
information on, or that can be accessed through, our website as part of this
prospectus.
RISK
FACTORS
An investment in our common stock
involves a high degree of risk. You should carefully consider the risks
described below, together with all of the other information included in this
prospectus, before making an investment decision. If any of the following
risks actually occurs, our business, financial condition or results of
operations could suffer. In that case, the trading price of our common
stock could decline, and you may lose all or part of your
investment.
We
have suffered significant operating losses for several years in our history and
we may not be able to again achieve profitability.
We had an
accumulated deficit of approximately $195 million and had an overall deficit in
stockholders’ equity as of March 31, 2010. Although we were profitable in
2000 and 2001, we incurred substantial losses in the years prior to that, and
again in subsequent years. The deficit resulted because we expended more
money in the course of researching, developing and enhancing our technology and
products and establishing our marketing and administrative organizations than we
generated in revenues, and because of the significant non-cash losses we have
recognized related to accounting for certain of the complex financial
instruments we have issued in recent years to fund our business. We expect
to continue to incur significant expenses in the foreseeable future, primarily
related to the completion of development and commercialization of Lymphoseek,
but also potentially related to RIGS and our device product lines. As a
result, we are sustaining substantial operating and net losses, and it is
possible that we will never be able to sustain or develop the revenue levels
necessary to again attain profitability.
Our
products and product candidates may not achieve the broad market acceptance they
need in order to be a commercial success.
Widespread
use of our handheld gamma detection devices is currently limited to one surgical
procedure, sentinel lymph node biopsy (SLNB), used in the diagnosis and
treatment of two primary types of cancer: melanoma and breast cancer.
While the adoption of SLNB within the breast and melanoma indications appears to
be widespread, we believe expansion of SLNB to other indications such as head
and neck, colorectal and prostate cancers is likely dependent on a better
lymphatic tissue targeting agent than is currently available. Without
expanded indications in which to apply SLNB, it is likely that gamma detection
devices will eventually reach market saturation. Our efforts and those of
our marketing and distribution partners may not result in significant demand for
our products, and the current demand for our products may decline.
Our
radiopharmaceutical product candidates, Lymphoseek and RIGScan CR, are still in
the process of development, and even if we are successful in commercializing
them, we cannot assure you that they will obtain significant market
acceptance.
We
may have difficulty raising additional capital, which could deprive us of
necessary resources.
We expect
to continue to devote significant capital resources to fund research and
development and to maintain existing and secure new manufacturing
capacity. In order to support the initiatives envisioned in our business
plan, we may need to raise additional funds through the sale of assets, public
or private debt or equity financing, collaborative relationships or other
arrangements. Our ability to raise additional financing depends on many
factors beyond our control, including the state of capital markets, the market
price of our common stock and the development or prospects for development of
competitive technology by others. Because our common stock is not listed
on a major stock market, many investors may not be willing or allowed to
purchase it or may demand steep discounts. Sufficient additional financing
may not be available to us or may be available only on terms that would result
in further dilution to the current owners of our common
stock.
We
believe that we have access to sufficient financial resources with which to fund
our operations or those of our subsidiaries for the foreseeable future.
Depending on market conditions and/or changes in our business plans, we may
raise capital in coming quarters under this registration statement or we may
consider other funding vehicles. The continuation of the depressed
worldwide financial conditions and stock market valuations may adversely affect
our ability to raise additional capital, either under facilities in place or
from new sources of capital. If we are unsuccessful in raising additional
capital, closing on financing under already agreed to terms, or the terms of
raising such capital are unacceptable, we may have to modify our business plan
and/or significantly curtail our planned development activities and other
operations.
In
December 2006, we entered into a common stock purchase agreement with Fusion
Capital, an Illinois limited liability company, to sell $6.0 million of our
common stock over a 24-month period which ended on November 21, 2008.
Through November 21, 2008, we sold to Fusion Capital under the agreement
7,568,671 shares for proceeds of $1.9 million. In December 2008, we
entered into an amendment to the agreement which gave us a right to sell an
additional $6.0 million of our common stock to Fusion Capital before March 1,
2011, along with the $4.1 million of the unsold balance of the $6.0 million we
originally had the right to sell to Fusion Capital under the original
agreement. In March 2010, we sold to Fusion Capital under the amended
agreement 540,541 shares for proceeds of $1.0 million. Subsequent to this
sale, the remaining aggregate amount of our common stock we can sell to Fusion
Capital is $9.1 million, and we have reserved a total of 10,113,459 shares of
our common stock for sale under the amended agreement. Our right to make
sales under the amended agreement is limited to $50,000 every two business days,
unless our stock price equals or exceeds $0.30 per share, in which case we can
sell greater amounts to Fusion Capital as the price of our common stock
increases. Fusion Capital does not have the right or any obligation to
purchase any shares on any business day that the market price of our common
stock is less than $0.20 per share. Assuming all 10,113,459 shares are
sold, the selling price per share would have to average approximately $0.90 for
us to receive the full $9.1 million remaining proceeds under the agreement as
amended. Assuming we sell to Fusion Capital all 10,113,459 shares at a
sale price of $2.09 per share (the closing sale price of the common stock on
July 30, 2010), we would receive the full remaining $9.1 million under the
agreement. Under the agreement, we have the right but not the obligation
to sell more than the 10,113,459 shares to Fusion Capital. As of the date
hereof, we do not currently have any plans or intent to sell to Fusion Capital
any shares beyond the 10,113,459 shares. However, if we elect to sell more
than the 10,113,459 shares, we must first register any additional shares we may
elect to sell to Fusion Capital under the Securities Act before we can sell such
additional shares.
The
extent to which we rely on Fusion Capital as a source of funding will depend on
a number of factors, including the prevailing market price of our common stock
and the extent to which we are able to secure working capital from other
sources, such as through the sale of our products. To the extent that we
are unable to make sales to Fusion Capital to meet our capital needs, or to the
extent that we decide not to make such sales because of excessive dilution or
other reasons, and if we are unable to generate sufficient revenues from sales
of our products, we will need to secure another source of funding in order to
satisfy our working capital needs. Even if we are able to access the full
$9.1 million potentially remaining under the agreement with Fusion Capital, we
may still need additional capital to fully implement our business, operating and
development plans. Should the financing we require to sustain our working
capital needs be unavailable or prohibitively expensive when we require it, the
consequences could be a material adverse effect on our business, operating
results, financial condition and prospects.
Clinical
trials for our radiopharmaceutical product candidates will be lengthy and
expensive and their outcome is uncertain.
Before
obtaining regulatory approval for the commercial sale of any product candidates,
we must demonstrate through preclinical testing and clinical trials that our
product candidates are safe and effective for use in humans. Conducting
clinical trials is a time consuming, expensive and uncertain process and may
take years to complete. During 2009, we successfully completed a Phase 3
clinical trial in patients with breast cancer or melanoma for our most advanced
radiopharmaceutical product candidate, Lymphoseek. We began enrolling
clinical subjects in a second Phase 3 trial for Lymphoseek in patients with head
and neck squamous cell carcinoma in the third quarter of 2009 and in a third
Phase 3 trial in subjects with breast cancer and melanoma in the third quarter
of 2010. While neither the second or third trials are required to be
completed in order to file our new drug application (NDA) for Lymphoseek,
these trials are intended to contribute additional data for safety evaluation
purposes and to support expanded post-marketing product labeling for
Lymphoseek. In late 2008, we obtained approval from the European Medicines
Agency (EMEA) for a Phase 3 clinical protocol for our next radiopharmaceutical
candidate, RIGScan CR, and we are preparing to approach FDA to obtain similar
clearance. Historically, the results from preclinical testing and early
clinical trials have often not been predictive of results obtained in later
clinical trials. Frequently, drugs that have shown promising results in
preclinical or early clinical trials subsequently fail to establish sufficient
safety and efficacy data necessary to obtain regulatory approval. At any
time during the clinical trials, we, the participating institutions, FDA or EMEA
might delay or halt any clinical trials for our product candidates for various
reasons, including:
|
·
|
ineffectiveness
of the product candidate;
|
|
·
|
discovery
of unacceptable toxicities or side
effects;
|
|
·
|
development
of disease resistance or other physiological
factors;
|
|
·
|
delays
in patient enrollment; or
|
|
·
|
other
reasons that are internal to the businesses of our potential collaborative
partners, which reasons they may not share with
us.
|
While we
have achieved some level of success in our recent Phase 2 and Phase 3 clinical
trials for Lymphoseek, the results of these clinical trials, as well as pending
and future trials, are subject to review and interpretation by various
regulatory bodies during the regulatory review process and may ultimately fail
to demonstrate the safety or effectiveness of our product candidates to the
extent necessary to obtain regulatory approval or such that commercialization of
our product candidates is worthwhile. Any failure or substantial delay in
successfully completing clinical trials and obtaining regulatory approval for
our product candidates could severely harm our business.
If
we fail to obtain collaborative partners, or those we obtain fail to perform
their obligations or discontinue clinical trials for particular product
candidates, our ability to develop and market potential products could be
severely limited.
Our
strategy for the development and commercialization of our product candidates
depends, in large part, upon the formation of collaborative arrangements.
Collaborations may allow us to:
|
·
|
generate
cash flow and revenue;
|
|
·
|
offset
some of the costs associated with our internal research and development,
preclinical testing, clinical trials and
manufacturing;
|
|
·
|
seek
and obtain regulatory approvals faster than we could on our own;
and
|
|
·
|
successfully
commercialize existing and future product
candidates.
|
We have
an agreement in place with Cardinal Health for the distribution of Lymphoseek in
the United States. We do not currently have collaborative agreements
covering Lymphoseek in other areas of the world or for RIGScan CR or ACT.
We cannot assure you that we will be successful in securing collaborative
partners for other markets or radiopharmaceutical products, or that we will be
able to negotiate acceptable terms for such arrangements. The development,
regulatory approval and commercialization of our product candidates will depend
substantially on the efforts of collaborative partners, and if we fail to secure
or maintain successful collaborative arrangements, or if our partners fail to
perform their obligations, our development, regulatory, manufacturing and
marketing activities may be delayed, scaled back or suspended.
We
rely on third parties for the worldwide marketing and distribution of our gamma
detection devices, who may not be successful in selling our
products.
We
currently distribute our gamma detection devices in most global markets through
partners who are solely responsible for marketing and distributing these
products. The partners assume direct responsibility for business risks
related to credit, currency exchange, foreign tax laws or tariff and trade
regulation. For the past ten years, our primary marketing and distribution
partner for our gamma detection devices has been Ethicon Endo-Surgery, Inc.
(EES), a Johnson & Johnson company. Recently, EES sold its breast care
franchise, the group that is responsible for selling our gamma detection
devices, to Devicor Medical Products, Inc. (Devicor). While we believe
that Devicor as our distribution partner intends to continue to aggressively
market our products, we cannot assure you that the distribution partner will
succeed in marketing our products on a global basis. We may not be able to
maintain satisfactory arrangements with our marketing and distribution partners,
who may not devote adequate resources to selling our products. If this
happens, we may not be able to successfully market our products, which would
decrease our revenues.
Our
radiopharmaceutical product candidates are subject to extensive government
regulations and we may not be able to obtain necessary regulatory
approvals.
We may
not receive the regulatory approvals necessary to commercialize our Lymphoseek
and RIGScan product candidates, which could cause our business to be severely
harmed. Our product candidates are subject to extensive and rigorous
government regulation. FDA regulates, among other things, the development,
testing, manufacture, safety, record-keeping, labeling, storage, approval,
advertising, promotion, sale and distribution of pharmaceutical products.
If our potential products are marketed abroad, they will also be subject to
extensive regulation by foreign governments. None of our
radiopharmaceutical product candidates have been approved for sale in the United
States or in any foreign market. The regulatory review and approval
process, which includes preclinical studies and clinical trials of each product
candidate, is lengthy, complex, expensive and uncertain. Securing FDA
clearance to market requires the submission of extensive preclinical and
clinical data and supporting information to FDA for each indication to establish
the product candidate's safety and efficacy. Data obtained from
preclinical and clinical trials are susceptible to varying interpretation, which
may delay, limit or prevent regulatory approval. The approval process may
take many years to complete and may involve ongoing requirements for
post-marketing studies. In light of the limited regulatory history of
monoclonal antibody-based therapeutics, regulatory approvals for our products
may not be obtained without lengthy delays, if at all. Any FDA or other
regulatory approvals of our product candidates, once obtained, may be
withdrawn. The effect of government regulation may be to:
|
·
|
delay
marketing of potential products for a considerable period of
time;
|
|
·
|
limit
the indicated uses for which potential products may be
marketed;
|
|
·
|
impose
costly requirements on our activities;
and
|
|
·
|
provide
competitive advantage to other pharmaceutical and biotechnology
companies.
|
We may
encounter delays or rejections in the regulatory approval process because of
additional government regulation from future legislation or administrative
action or changes in FDA policy during the period of product development,
clinical trials and FDA regulatory review. Failure to comply with
applicable FDA or other regulatory requirements may result in criminal
prosecution, civil penalties, recall or seizure of products, total or partial
suspension of production or injunction, as well as other regulatory action
against our product candidates or us. Outside the United States, our
ability to market a product is contingent upon receiving clearances from the
appropriate regulatory authorities. This foreign regulatory approval
process includes risks similar to those associated with FDA approval
process.
Our
radiopharmaceutical product candidates will remain subject to ongoing regulatory
review even if they receive marketing approval. If we fail to comply with
continuing regulations, we could lose these approvals and the sale of our
products could be suspended.
Even if
we receive regulatory clearance to market a particular product candidate, the
approval could be conditioned on us conducting additional costly post-approval
studies or could limit the indicated uses included in our labeling.
Moreover, the product may later cause adverse effects that limit or prevent its
widespread use, force us to withdraw it from the market or impede or delay our
ability to obtain regulatory approvals in additional countries. In
addition, the manufacturer of the product and its facilities will continue to be
subject to FDA review and periodic inspections to ensure adherence to applicable
regulations. After receiving marketing clearance, the manufacturing,
labeling, packaging, adverse event reporting, storage, advertising, promotion
and record-keeping related to the product will remain subject to extensive
regulatory requirements. We may be slow to adapt, or we may never adapt,
to changes in existing regulatory requirements or adoption of new regulatory
requirements.
If we
fail to comply with the regulatory requirements of FDA and other applicable U.S.
and foreign regulatory authorities or previously unknown problems with our
products, manufacturers or manufacturing processes are discovered, we could be
subject to administrative or judicially imposed sanctions,
including:
|
·
|
restrictions
on the products, manufacturers or manufacturing
processes;
|
|
·
|
civil
or criminal penalties;
|
|
·
|
product
seizures or detentions;
|
|
·
|
voluntary
or mandatory product recalls and publicity
requirements;
|
|
·
|
suspension
or withdrawal of regulatory
approvals;
|
|
·
|
total
or partial suspension of production;
and
|
|
·
|
refusal
to approve pending applications for marketing approval of new drugs or
supplements to approved
applications.
|
Our
existing products are highly regulated and we could face severe problems if we
do not comply with all regulatory requirements in the global markets in which
these products are sold.
FDA
regulates our gamma detection products in the United States. Foreign
countries also subject these products to varying government regulations.
In addition, these regulatory authorities may impose limitations on the use of
our products. FDA enforcement policy strictly prohibits the marketing of
FDA cleared medical devices for unapproved uses. Within the European
Union, our products are required to display the CE Mark in order to be
sold. We have obtained FDA clearance to market and European certification
to display the CE Mark on our current line of gamma detection systems. We
may not be able to obtain clearance to market any new products in a timely
manner, or at all. Failure to comply with these and other current and
emerging regulatory requirements in the global markets in which our products are
sold could result in, among other things, warning letters, fines, injunctions,
civil penalties, recall or seizure of products, total or partial suspension of
production, refusal of the government to grant pre-market clearance for devices,
withdrawal of clearances, and criminal prosecution.
We
rely on third parties to manufacture our medical device products and our
business will suffer if they do not perform.
We rely
on independent contract manufacturers for the manufacture of our current
neoprobe GDS line of gamma detection systems. Our business will suffer if
our contract manufacturers have production delays or quality problems.
Furthermore, medical device manufacturers are subject to the quality system
regulations of FDA, international quality standards, and other regulatory
requirements. If our contractors do not operate in accordance with
regulatory requirements and quality standards, our business will suffer.
We use or rely on components and services used in our devices that are provided
by sole source suppliers. The qualification of additional or replacement
vendors is time consuming and costly. If a sole source supplier has
significant problems supplying our products, our sales and revenues will be hurt
until we find a new source of supply. In addition, our distribution
agreement with Devicor for our gamma detection devices contains failure to
supply provisions, which, if triggered, could have a significant negative impact
on our business.
We
may be unable to establish the pharmaceutical manufacturing capabilities
necessary to develop and commercialize our potential products.
We do not
have our own manufacturing facility for the manufacture of the
radiopharmaceutical compounds necessary for clinical testing or commercial
sale. We intend to rely on third-party contract manufacturers to produce
sufficiently large quantities of drug materials that are and will be needed for
clinical trials and commercialization of our potential products.
Third-party manufacturers may not be able to meet our needs with respect to
timing, quantity or quality of materials. We have completed a supply
agreement with Reliable Biopharmaceuticals covering the manufacturing of the
active pharmaceutical ingredient in Lymphoseek and we are in the process of
finalizing supply contracts with another third-party manufacturer for the
lyophoization, vialing and filling of the finished Lymphoseek product.
However, if we are unable to contract for a sufficient supply of needed
materials on acceptable terms, or if we should encounter delays or difficulties
in our relationships with manufacturers, our clinical trials may be delayed,
thereby delaying the submission of product candidates for regulatory approval
and the market introduction and subsequent commercialization of our potential
products. Any such delays may lower our revenues and potential
profitability.
We and
any third-party manufacturers that we may use must continually adhere to current
Good Manufacturing Practices regulations enforced by FDA through its facilities
inspection program. If our facilities or the facilities of third-party
manufacturers cannot pass a pre-approval plant inspection, FDA will not grant
approval to our product candidates. In complying with these regulations
and foreign regulatory requirements, we and any of our third-party manufacturers
will be obligated to expend time, money and effort on production, record-keeping
and quality control to assure that our potential products meet applicable
specifications and other requirements. If we or any third-party
manufacturer with whom we may contract fail to maintain regulatory compliance,
we or the third party may be subject to fines and/or manufacturing operations
may be suspended.
Unfavorable
pricing regulations, third-party reimbursement practices or healthcare reform
initiatives applicable to our radiopharmaceutical products and product
candidates could limit our potential product revenue and adversely affect our
business.
The
regulations governing drug pricing and reimbursement vary widely from country to
country. Some countries require approval of the sale price of a drug
before it can be marketed and, in many of these countries, the pricing review
period begins only after approval is granted. In some countries,
prescription pharmaceutical pricing remains subject to continuing governmental
control even after initial approval is granted. Although we monitor these
regulations, our product candidates are currently in the development stage and
we will not be able to assess the impact of price regulations for at least
several years. As a result, we may obtain regulatory approval for a
product in a particular country, but then be subject to price regulations that
may delay the commercial launch of the product and may negatively impact the
revenues we are able to derive from sales in that country.
The
healthcare industry is undergoing fundamental changes resulting from political,
economic and regulatory influences. In the United States, comprehensive
programs have been proposed that seek to increase access to healthcare for the
uninsured, to control the escalation of healthcare expenditures within the
economy and to use healthcare reimbursement policies to balance the federal
budget. On March 23, 2010, health reform legislation was approved by
Congress and has been signed into law. The reform legislation provides
that most individuals must have health insurance, will establish new regulations
on health plans, create insurance pooling mechanisms and other expanded public
health care measures, and impose new taxes on sales of medical devices and
pharmaceuticals. Since this legislation was recently enacted and will
require the adoption of implementing regulations, we cannot predict the effect,
if any, that it will have on our business, but this legislation and similar
federal and state initiatives may have the effect of lowering reimbursements for
our products, reducing medical procedure volumes, increasing our taxes and
otherwise adversely affect our business, possibly materially.
We expect
that Congress and state legislatures will continue to review and assess
healthcare proposals, and public debate of these issues will likely
continue. We cannot predict which, if any, of such reform proposals will
be adopted and when they might be adopted. Other countries also are
considering healthcare reform. Significant changes in healthcare systems
could have a substantial impact on the manner in which we conduct our business
and could require us to revise our strategies.
The
sale of our common stock to Fusion may cause dilution and the sale of common
stock acquired by Fusion could cause the price of our common stock to
decline.
In
connection with our agreement with Fusion Capital, we have authorized the sale
of up to 18,222,671 shares of our common stock and the issuance of 1,800,000
shares in commitment fees, and we have filed a registration statement with the
SEC for the sale to the public of 11,500,000 shares issuable to Fusion Capital
pursuant to the agreement. Through July 30, 2010, we have sold Fusion
Capital 8,109,212 shares of common stock and issued 1,434,000 shares of stock as
commitment fees to Fusion Capital. The number of shares ultimately offered
for sale to the public will be dependent upon the number of shares purchased by
Fusion Capital under the agreement. It is anticipated that these shares
will be sold over a period of up to 26 months from the date of the December 24,
2008 amendment to the agreement, at prices that will fluctuate based on changes
in the market price of our common stock over that period. Depending upon
market liquidity at the times sales are made, these sales could cause the market
price of our common stock to decline. Consequently, sales to Fusion
Capital may result in substantial dilution to the interests of other holders of
our common stock. The sale of a substantial number of shares of our common
stock by Fusion Capital, or anticipation of such sales, could make it more
difficult for us to sell equity or equity-related securities in the future at a
time and at a price that we might otherwise wish to effect sales. However,
we have the right to control the timing and amount of any sales of our shares to
Fusion Capital and the agreement may be terminated by us at any time at our
discretion without any cost to us.
The
sale of the shares of common stock acquired in private placements could cause
the price of our common stock to decline.
Over the
past few years, we completed various financings in which we issued common stock,
convertible notes, warrants and other securities convertible into common stock
to certain private investors. The terms of these transactions require that
we file registration statements with the Securities and Exchange Commission
under which the investors may resell to the public common stock acquired in
these transactions, as well as common stock acquired on the exercise of the
warrants and convertible securities held by them. Further, some or all of
the common stock sold in these transactions may become eligible for resale
without registration under the provisions of Rule 144, upon satisfaction of the
holding period and other requirements of the Rule.
As
required by our financing arrangements with Fusion Capital, we have filed a
registration statement registering for resale a total of 11,500,000 common
shares, consisting of (i) 10,654,000 shares which we may sell to Fusion Capital
pursuant to the amended common stock purchase agreement, (ii) 360,000 shares
issued to Fusion Capital in consideration for its agreement to the amendment;
and (iii) 486,000 commitment fee shares to be issued pro rata as we sell the
first $4.1 million of common stock under the amended agreement. The number
of shares ultimately sold under the registration statement will be dependent
upon the number of shares purchased by Fusion Capital under the amended
agreement. It is anticipated that these shares will be sold from time to
time over a period ending on March 1, 2011, at prices that will fluctuate based
on changes in the market price of our common stock over that period. We
have the right to control the timing and amount of any sales of our shares to
Fusion Capital and the agreement may be terminated by us at any time at our
discretion without any cost to us.
On
December 26, 2007, we entered into a Securities Purchase Agreement (SPA) with
Platinum-Montaur Life Sciences, LLC (Montaur), pursuant to which we issued
Montaur a 10% Series A Convertible Senior Secured Promissory Note in the
principal amount of $7,000,000, due December 26, 2011 (the Series A Note) and a
five-year Series W Warrant to purchase 6,000,000 shares of our common stock at
an exercise price of $0.32 per share. On April 16, 2008, following receipt
by the Company of clearance by the FDA to commence a Phase 3 clinical trial for
Lymphoseek in patients with breast cancer or melanoma, we amended the SPA and
issued Montaur a 10% Series B Convertible Senior Secured Promissory Note in the
principal amount of $3,000,000, also due December 26, 2011 (the Series B Note,
and hereinafter referred to collectively with the Series A Note as the Montaur
Notes), and a five-year Series X Warrant to purchase 8,333,333 shares of our
common stock at an exercise price of $0.46 per share. On December 5, 2008,
after the Company had obtained 135 vital blue dye lymph nodes from patients who
had completed surgery and the injection of the drug in the Phase 3 clinical
trial of Lymphoseek in patients with breast cancer or melanoma, we issued
Montaur 3,000 shares of our 8% Series A Cumulative Convertible Preferred Stock
(the Series A Preferred Stock) and a five-year Series Y Warrant (hereinafter
referred to collectively with the Series W Warrant and Series X Warrant as the
Montaur Warrants) to purchase 6,000,000 shares of our common stock, at an
exercise price of $0.575 per share, also for an aggregate purchase price of
$3,000,000. On July 24, 2009, we entered into a Securities Amendment and
Exchange Agreement (Amendment Agreement) with Montaur, pursuant to which Montaur
agreed to the amendment and restatement of the terms of the Montaur Notes, the
Montaur Warrants and the Preferred Stock, to remove price-based anti-dilution
adjustment provisions that had created a significant non-cash derivative
liability on the Company’s balance sheet, and upon the surrender of the Montaur
Notes and the Montaur Warrants we issued Montaur an Amended and Restated 10%
Series A Convertible Senior Secured Promissory Note in the principal amount of
$7,000,000, due December 26, 2011 (the Amended Series A Note), an Amended and
Restated 10% Series B Convertible Senior Secured Promissory Note in the
principal amount of $3,000,000, due December 26, 2011 (the Amended Series B
Note, and together with the Amended Series A Note the Amended Montaur Notes), an
Amended and Restated Series W Warrant (the Amended Series W Warrant), an Amended
and Restated Series X Warrant (the Amended Series X Warrant), an Amended and
Restated Series Y Warrant (the Amended Series Y Warrant), and in consideration
for the agreement of Montaur to enter into the Amendment Agreement, a Series AA
Warrant to purchase 2,400,000 shares of our common stock at an exercise price of
$0.97 per share (the Series AA Warrant, and together with the Amended Series W
Warrant, Amended Series X Warrant and Amended Series Y Warrant, the Amended
Montaur Warrants). On June 22, 2010, we entered into a Securities Exchange
Agreement (the Exchange Agreement) with Montaur, pursuant to which Montaur
delivered to the Company for cancellation and retirement: (1) the Amended
Montaur Notes; and (2) the Series A Preferred Stock, in exchange for 10,000
shares of our Series B Convertible Preferred Stock (Series B Preferred Stock).
Pursuant to the provisions of the Certificate of Designations, Voting Powers,
Preferences, Limitations, Restrictions, and Relative Rights of the Series B
Convertible Preferred Stock, Montaur may convert all or any portion of the
shares of the Series B Preferred Stock into an aggregate 32,700,000 shares of
our common stock, subject to adjustment as described in the Certificate of
Designations.
Montaur
may sell none, some or all of the shares of common stock acquired from us, as
well as common stock acquired on the exercise of the warrants and convertible
securities held by them. We have no way of knowing whether or when Montaur
will sell these shares. Depending upon market liquidity at the time, a
sale of these shares at any given time could cause the trading price of our
common stock to decline. The sale of a substantial number of shares of our
common stock, or anticipation of such sales, could make it more difficult for us
to sell equity or equity-related securities in the future at a time and at a
price that we might otherwise wish to effect sales.
We
may lose out to larger and better-established competitors.
The
medical device and biotechnology industries are intensely competitive.
Some of our competitors have significantly greater financial, technical,
manufacturing, marketing and distribution resources as well as greater
experience in the medical device industry than we have. The particular
medical conditions our product lines address can also be addressed by other
medical devices, procedures or drugs. Many of these alternatives are
widely accepted by physicians and have a long history of use. Physicians
may use our competitors’ products and/or our products may not be competitive
with other technologies. If these things happen, our sales and revenues
will decline. In addition, our current and potential competitors may
establish cooperative relationships with large medical equipment companies to
gain access to greater research and development or marketing resources.
Competition may result in price reductions, reduced gross margins and loss of
market share.
Our
products may be displaced by newer technology.
The
medical device and biotechnology industries are undergoing rapid and significant
technological change. Third parties may succeed in developing or marketing
technologies and products that are more effective than those developed or
marketed by us, or that would make our technology and products obsolete or
non-competitive. Additionally, researchers could develop new surgical
procedures and medications that replace or reduce the importance of the
procedures that use our products. Accordingly, our success will depend, in
part, on our ability to respond quickly to medical and technological changes
through the development and introduction of new products. We may not have
the resources to do this. If our products become obsolete and our efforts
to develop new products do not result in any commercially successful products,
our sales and revenues will decline.
We
may not have sufficient legal protection against infringement or loss of our
intellectual property, and we may lose rights to our licensed intellectual
property if diligence requirements are not met.
Our
success depends, in part, on our ability to secure and maintain patent
protection, to preserve our trade secrets, and to operate without infringing on
the patents of third parties. While we seek to protect our proprietary
positions by filing United States and foreign patent applications for our
important inventions and improvements, domestic and foreign patent offices may
not issue these patents. Third parties may challenge, invalidate, or
circumvent our patents or patent applications in the future. Competitors,
many of which have significantly more resources than we have and have made
substantial investments in competing technologies, may apply for and obtain
patents that will prevent, limit, or interfere with our ability to make, use, or
sell our products either in the United States or abroad.
In the
United States, patent applications are secret until patents are issued, and in
foreign countries, patent applications are secret for a time after filing.
Publications of discoveries tend to significantly lag the actual discoveries and
the filing of related patent applications. Third parties may have already
filed applications for patents for products or processes that will make our
products obsolete or will limit our patents or invalidate our patent
applications.
We
typically require our employees, consultants, advisers and suppliers to execute
confidentiality and assignment of invention agreements in connection with their
employment, consulting, advisory, or supply relationships with us. They
may breach these agreements and we may not obtain an adequate remedy for
breach. Further, third parties may gain access to our trade secrets or
independently develop or acquire the same or equivalent
information.
Agencies
of the United States government conducted some of the research activities that
led to the development of antibody technology that some of our proposed
antibody-based surgical cancer detection products use. When the United
States government participates in research activities, it retains rights that
include the right to use the technology for governmental purposes under a
royalty-free license, as well as rights to use and disclose technical data that
could preclude us from asserting trade secret rights in that data and
software.
We
may lose the license rights to certain in-licensed products if we do not
exercise adequate diligence.
Our
license agreements for Lymphoseek, RIGS, and ACT contain provisions that require
that we demonstrate ongoing diligence in the continuing research and development
of these potential products. Cira Bio’s rights to certain applications of
the ACT technology may be affected by its failure to achieve certain capital
raising milestones although no such notices to that effect have been received to
date. We have provided information, as required or requested, to the
licensors of our technology indicating the steps we have taken to demonstrate
our diligence and believe we are adequately doing so to meet the terms and/or
intent of our license agreements. However, it is possible that the
licensors may not consider our actions adequate in demonstrating such
diligence. Should we fail to demonstrate the requisite diligence required
by any such agreements or as interpreted by the respective licensors, we may
lose our development and commercialization rights for the associated
product.
We
could be damaged by product liability claims.
Our
products are used or intended to be used in various clinical or surgical
procedures. If one of our products malfunctions or a physician misuses it
and injury results to a patient or operator, the injured party could assert a
product liability claim against our Company. We currently have product
liability insurance with a $10 million per occurrence limit, which we believe is
adequate for our current activities. However, we may not be able to
continue to obtain insurance at a reasonable cost. Furthermore, insurance
may not be sufficient to cover all of the liabilities resulting from a product
liability claim, and we might not have sufficient funds available to pay any
claims over the limits of our insurance. Because personal injury claims
based on product liability in a medical setting may be very large, an
underinsured or an uninsured claim could financially damage our
Company.
We
may have difficulty attracting and retaining qualified personnel and our
business may suffer if we do not.
Our
business has experienced a number of successes and faced several challenges in
recent years that have resulted in several significant changes in our strategy
and business plan, including the shifting of resources to support our current
product initiatives. Our management will need to remain flexible to
support our business model over the next few years. However, losing
members of the Neoprobe management team could have an adverse effect on our
operations. Our success depends on our ability to attract and retain
technical and management personnel with expertise and experience in the medical
device business. The competition for qualified personnel in the
biotechnology industry is intense and we may not be successful in hiring or
retaining the requisite personnel. If we are unable to attract and retain
qualified technical and management personnel, we will suffer diminished chances
of future success.
Our
common stock is traded over the counter, which may deprive stockholders of the
full value of their shares.
Our
common stock is quoted via the OTC Bulletin Board (OTCBB). As such, our
common stock may have fewer market makers, lower trading volumes and larger
spreads between bid and ask prices than securities listed on an exchange such as
the New York Stock Exchange or the NASDAQ Stock Market. These factors may
result in higher price volatility and less market liquidity for the common
stock.
A
low market price may severely limit the potential market for our common
stock.
Our
common stock is currently trading at a price substantially below $5.00 per
share, subjecting trading in the stock to certain SEC rules requiring additional
disclosures by broker-dealers. These rules generally apply to any
non-NASDAQ equity security that has a market price share of less than $5.00 per
share, subject to certain exceptions (a "penny stock"). Such rules require
the delivery, prior to any penny stock transaction, of a disclosure schedule
explaining the penny stock market and the risks associated therewith and impose
various sales practice requirements on broker-dealers who sell penny stocks to
persons other than established customers and institutional or wealthy
investors. For these types of transactions, the broker-dealer must make a
special suitability determination for the purchaser and have received the
purchaser's written consent to the transaction prior to the sale. The
broker-dealer also must disclose the commissions payable to the broker-dealer,
current bid and offer quotations for the penny stock and, if the broker-dealer
is the sole market maker, the broker-dealer must disclose this fact and the
broker-dealer's presumed control over the market. Such information must be
provided to the customer orally or in writing before or with the written
confirmation of trade sent to the customer. Monthly statements must be
sent disclosing recent price information for the penny stock held in the account
and information on the limited market in penny stocks. The additional
burdens imposed upon broker-dealers by such requirements could discourage
broker-dealers from effecting transactions in our common stock.
The
price of our common stock has been highly volatile due to several factors that
will continue to affect the price of our stock.
Our
common stock traded as low as $0.95 per share and as high as $2.30 per share
during the 12-month period ended July 31, 2010. The market price of our
common stock has been and is expected to continue to be highly volatile.
Factors, including announcements of technological innovations by us or other
companies, regulatory matters, new or existing products or procedures, concerns
about our financial position, operating results, litigation, government
regulation, developments or disputes relating to agreements, patents or
proprietary rights, may have a significant impact on the market price of our
stock. In addition, potential dilutive effects of future sales of shares
of common stock by the Company and by stockholders, and subsequent sale of
common stock by the holders of warrants and options could have an adverse effect
on the market price of our shares.
Some
additional factors which could lead to the volatility of our common stock
include:
|
·
|
price
and volume fluctuations in the stock market at large which do not relate
to our operating performance;
|
|
·
|
financing
arrangements we may enter that require the issuance of a significant
number of shares in relation to the number of shares currently
outstanding;
|
|
·
|
public
concern as to the safety of products that we or others develop;
and
|
|
·
|
fluctuations
in market demand for and supply of our
products.
|
An
investor’s ability to trade our common stock may be limited by trading
volume.
Generally,
the trading volume for our common stock has been relatively limited. A
consistently active trading market for our common stock may not occur on the
OTCBB. The average daily trading volume for our common stock on the OTCBB
for the 12-month period ended July 31, 2010 was approximately 125,000
shares.
Some
provisions of our organizational and governing documents may have the effect of
deterring third parties from making takeover bids for control of our Company or
may be used to hinder or delay a takeover bid.
Our
certificate of incorporation authorizes the creation and issuance of “blank
check” preferred stock. Our Board of Directors may divide this stock into
one or more series and set their rights. The Board of Directors may,
without prior stockholder approval, issue any of the shares of “blank check”
preferred stock with dividend, liquidation, conversion, voting or other rights,
which could adversely affect the relative voting power or other rights of the
common stock. Preferred stock could be used as a method of discouraging,
delaying, or preventing a take-over of our Company. If we issue “blank
check” preferred stock, it could have a dilutive effect upon our common
stock. This would decrease the chance that our stockholders would realize
a premium over market price for their shares of common stock as a result of a
takeover bid.
Because
we will not pay dividends in the foreseeable future, stockholders will only
benefit from owning common stock if it appreciates.
We have
never paid dividends on our common stock and we do not intend to do so in the
foreseeable future. We intend to retain any future earnings to finance our
growth. Accordingly, any potential investor who anticipates the need for
current dividends from his investment should not purchase our common
stock.
SPECIAL NOTE REGARDING FORWARD-LOOKING
STATEMENTS
This prospectus and the information
incorporated by reference in this prospectus contain forward-looking
statements. We sometimes use words such as “anticipate,” “believe,”
“continue,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “will” and similar expressions, as they relate
to us, our management and our industry, to identify forward-looking
statements. Forward-looking statements relate to our expectations,
beliefs, plans, strategies, prospects, future performance, anticipated trends
and other future events. Specifically, this prospectus and the information
incorporated by reference in this prospectus contain forward-looking statements
relating to, among other things:
|
·
|
our
primary operating costs and
expenses;
|
|
·
|
evaluation
of possible acquisitions of, or investments in business, products and
technologies; and
|
|
·
|
sufficiency
of existing cash to meet operating
requirements.
|
These statements involve known and
unknown risks, uncertainties, and other factors that may cause our or our
industry’s past results, levels of activity, performance, or achievements to be
materially different from any future results, levels of activity, performance,
or achievements expressed or implied by such forward-looking statements.
Actual results may differ materially. Some of the risks, uncertainties and
assumptions that may cause actual results to differ from these forward-looking
statements are described in “Risk Factors” and elsewhere in this prospectus, and
may also be found in an accompanying prospectus supplement and in information
incorporated by reference.
You should read this prospectus, the
documents that we filed as exhibits to the registration statement of which this
prospectus is a part and the documents that we incorporate by reference in this
prospectus completely and with the understanding that our future results may be
materially different from what we expect. We qualify all of our
forward-looking statements by these cautionary statements, and we assume no
obligation to update these forward-looking statements publicly for any
reason.
CAPITALIZATION
The
following table sets forth our other long-term assets, debt and capitalization
as of March 31, 2010, as follows:
|
·
|
on
an actual basis; and
|
|
·
|
on
a pro forma basis to give effect to the exchange of the Montaur Notes and
the Series A Preferred Stock for Series B Preferred Stock, and the
exchange of the Amended 10% Convertible Note in the principal amount of
$1,000,000, due December 31, 2011, executed by the Company in favor
of David C. Bupp, our President and CEO, and certain members of his family
(the Bupp Note), for Series C Preferred
Stock.
|
The table
does not include the effect of the shares registered in this Registration
Statement as the shares registered are: (1) for a secondary offering by selling
shareholders; and (2) the sale of an undetermined number and amount of primary
shares.
|
|
March 31, 2010
Actual (Unaudited)
|
|
|
Adjustments
|
|
|
March 31, 2010
Pro Forma
|
|
|
|
|
|
|
|
|
|
|
|
Other
assets
|
|
|
22,534 |
|
|
|
(13,061 |
)
(1) |
|
|
9,473 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
3,422,520 |
|
|
|
- |
|
|
|
3,422,520 |
|
Long-term
liabilities
|
|
|
13,882,180 |
|
|
|
(11,923,791 |
)
(1)(2)(3) |
|
|
1,958,389 |
|
Preferred
stock
|
|
|
3,000,000 |
|
|
|
(3,000,000 |
)
(2) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
(deficit) equity:
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
stock
|
|
|
- |
|
|
|
11 |
(1)(2)(3) |
|
|
11 |
|
Common
stock
|
|
|
81,892 |
|
|
|
|
|
|
|
81,892 |
|
Additional
paid-in capital
|
|
|
184,096,762 |
|
|
|
64,666,789 |
(1)(2)(3) |
|
|
248,763,551 |
|
Accumulated
deficit
|
|
|
(195,218,800 |
) |
|
|
(49,756,070 |
)
(1)(2)(3) |
|
|
(244,974,870 |
) |
Total
stockholders’ (deficit) equity
|
|
|
(11,040,146 |
) |
|
|
14,910,730 |
|
|
|
3,870,584 |
|
Total
capitalization
|
|
$ |
9,264,554 |
|
|
|
|
|
|
$ |
9,251,493 |
|
|
(1)
|
As
a result of exchanging the Montaur Notes for Series B Preferred Stock, the
Company decreased other assets by $13,061 and long-term liabilities by
$10,750,000, and increased preferred stock by $8 and additional paid-in
capital by $47,605,302. The Company also increased accumulated
deficit by recognizing a loss on the extinguishment of the Montaur Notes
of $36,868,371.
|
|
(2)
|
As
a result of exchanging the Series A Preferred Stock for Series B Preferred
Stock, the Company decreased mezzanine preferred stock by $3,000,000 and
long-term liabilities by $216,000, and increased preferred stock by $2 and
additional paid-in capital by $11,254,688. The Company also
increased accumulated deficit by recognizing a deemed dividend on the
Series A Preferred Stock of
$8,038,690.
|
|
(3)
|
As
a result of exchanging the Bupp Note for Series C Preferred Stock, the
Company decreased long-term liabilities by $957,791 and increased
preferred stock by $1 and additional paid-in capital by $5,806,799.
The Company also increased accumulated deficit by recognizing a loss on
the extinguishment of the Bupp Note of
$4,849,009.
|
WHERE
YOU CAN FIND MORE INFORMATION
AND
INCORPORATION BY REFERENCE
We have filed a registration statement
on Form S-3 with the Securities and Exchange Commission. This
prospectus does not contain all of the information in the registration
statement. In addition, we file annual, quarterly and special reports,
proxy statements and other information with the Commission. Our Commission
filings are available to the public over the Internet at the Commission’s web
site at http://www.sec.gov. You may also read and copy any document we
file with the Commission at its public reference facilities at 100 F Street,
N.E., Washington, DC 20549. You can also obtain copies of the documents at
prescribed rates by writing to the Public Reference Section of the Commission at
100 F Street, N.E., Washington, DC 20549. Please call the Commission at
1-800-SEC-0330 for further information on the operation of the public reference
facilities.
We “incorporate by reference” into this
prospectus the information we file with the Commission (Commission file number
0-26520), which means that we can disclose important information to you by
referring you to those documents. The information incorporated by
reference is an important part of this prospectus. Information that we
file with the Commission after the date of this prospectus will automatically
update this prospectus. We incorporate by reference the documents listed
below, and any filings we make with the Commission under Sections 13(a),
13(c), 14, or 15(d) of the Securities Exchange Act of 1934 after the
initial filing of the registration statement that contains this prospectus
(except for information furnished and not filed with the Commission in a Current
Report on Form 8-K):
|
·
|
our
Annual Report on Form 10-K for the year ended December 31, 2009, filed
with the Commission on March 31,
2010;
|
|
·
|
our
Quarterly Report on Form 10-Q for the quarterly period ended March 31,
2010, filed with the Commission on May 14,
2010;
|
|
·
|
our
Current Reports on Form 8-K, dated January 11, 2010 (filed January 11,
2010), dated January 26, 2010 (filed January 28, 2010), dated February 24,
2010 (filed February 26, 2010), dated March 11, 2010 (filed March 12,
2010), dated May 26, 2010 (filed May 27, 2010), dated June 22, 2010 (filed
June 28, 2010) and dated July 16, 2010 (filed July 20, 2010);
and
|
|
·
|
the
description of our common stock which is contained in our Form 8-A filed
with the Commission pursuant to Section 12 of the Securities Exchange Act
of 1934, as amended, as updated in any amendment or report filed for the
purpose of updating such
description.
|
Information
furnished by us in Current Reports on Form 8-K under Items 2.02 and 9.01 is
expressly not incorporated by reference in this
prospectus.
We will provide to each person,
including any beneficial owner, to whom a prospectus is delivered, without
charge, upon written or oral request, a copy of any or all of the documents that
are incorporated by reference into this prospectus but not delivered with the
prospectus, including exhibits that are specifically incorporated by reference
into such documents. You may request a copy of these filings at no cost,
by writing to or telephoning us at:
Neoprobe
Corporation
Attn:
Brent L. Larson
425 Metro
Place North
Dublin,
Ohio 43017-1367
(614)
822-2330
USE
OF PROCEEDS
Unless otherwise indicated in the
prospectus supplement, we intend to use the net proceeds from the sale of
securities under this prospectus for general corporate purposes, which may
include additions to working capital, repayment or redemption of existing
indebtedness and financing capital expenditures and acquisitions. The prospectus
supplement relating to a particular offering of securities by us will identify
the use of proceeds for that offering. We will receive no proceeds from
the sale of securities by the selling stockholders.
DESCRIPTION
OF CAPITAL STOCK
The following description of our
capital stock is only a summary and is subject to the provisions of our amended
and restated certificate of incorporation, or certificate of incorporation, and
our amended and restated by-laws, or by-laws, which are included as exhibits to
the registration statement of which this prospectus forms a part, and provisions
of applicable law.
Our articles of incorporation authorize
our board of directors to issue 200,000,000 shares of common stock and 5,000,000
shares of preferred stock. As of July 31, 2010, 82,280,755 shares of
common stock were issued outstanding, and 11,000 shares of preferred stock were
issued and outstanding.
Common
Stock
Dividends
Each
share of common stock is entitled to receive an equal dividend, if one is
declared, which is unlikely. We have never paid dividends on our common stock
and do not intend to do so in the foreseeable future. We intend to retain any
future earnings to finance our growth. See Risk Factors.
Liquidation
If our
company is liquidated, any assets that remain after the creditors are paid, and
the owners of preferred stock receive any liquidation preferences, will be
distributed to the owners of our common stock pro-rata.
Voting
Rights
Each
share of our common stock entitles the owner to one vote. There is no cumulative
voting. A simple majority can elect all of the directors at a given meeting and
the minority would not be able to elect any directors at that
meeting.
Preemptive
Rights
Owners of
our common stock have no preemptive rights. We may sell shares of our common
stock to third parties without first offering it to current
stockholders.
Redemption
Rights
We do not
have the right to buy back shares of our common stock except in extraordinary
transactions such as mergers and court approved bankruptcy reorganizations.
Owners of our common stock do not ordinarily have the right to require us to buy
their common stock. We do not have a sinking fund to provide assets for any buy
back.
Conversion
Rights
Shares of
our common stock can not be converted into any other kind of stock except in
extraordinary transactions, such as mergers and court approved bankruptcy
reorganizations.
Preferred
Stock
Our
certificate of incorporation authorizes our board of directors to issue "blank
check" preferred stock. The board of directors may divide this stock into series
and set their rights. On December 26, 2007, the board of directors designated
3,000 shares of preferred stock as Series A 8% Cumulative Convertible Preferred
Stock. On December 5, 2008, we issued 3,000 shares of Series A 8% Cumulative
Convertible Preferred Stock (Series A Preferred Stock) to Montaur. On June 22,
2010, the board of directors designated 10,000 shares of preferred stock as
Series B Convertible Preferred Stock (Series B Preferred Stock), and 1,000
shares of preferred stock as Series C Convertible Preferred Stock (Series C
Preferred Stock). Also, on June 22, 2010: (1) Montaur surrendered the Amended
Series A Note and all 3,000 shares of Series A Preferred Stock issued to it on
December 5, 2008, in exchange for 10,000 shares of Series B Preferred Stock; and
(2) we issued 1,000 shares of Series C Preferred Stock to David C. Bupp, the
Company’s President and Chief Executive Officer, and Cynthia B. Gochoco, both
individually and as co-executors of the Estate of Walter H. Bupp (the Bupp
Investors). Montaur may convert all or any portion of the shares of Series B
Preferred Stock into an aggregate 32,700,000 shares of our common stock, and the
Bupp Investors may convert all or any portion of the shares of Series C
Preferred Stock into an aggregate 3,226,000 shares of our common
stock.
The board
of directors may, without prior stockholder approval, issue any of the remaining
4,989,000 shares of authorized preferred stock with dividend, liquidation,
conversion, voting or other rights which could adversely affect the relative
voting power or other rights of the common stock. Preferred stock could be used
as a method of discouraging, delaying, or preventing a take-over of our Company.
If we do issue preferred stock in the future, it could have a dilutive effect
upon the common stock. See Risk Factors.
DESCRIPTION
OF WARRANTS
We may
issue warrants for the purchase of common stock in one or more series. We may
issue warrants independently or together with common stock, and the warrants may
traded separate and apart from our common stock. Each series of warrants will be
issued under a warrant agreement, as described in the applicable prospectus
supplement. We urge you to read any applicable warrant agreements, because those
documents, and not these descriptions, define your rights as a holder of
warrants. A copy of the form of warrant agreement reflecting the provisions of
the warrants in a particular offering will be filed as an exhibit to a Current
Report on Form 8-K, to be incorporated into the registration statement of which
this prospectus constitutes a part prior to the issuance of any
warrants.
The
applicable prospectus supplement will describe the terms of the warrants offered
thereby and the warrant agreement relating to such warrants, including but not
limited to the following:
|
·
|
the
offering price or prices;
|
|
·
|
the
aggregate amount of common stock that may be purchased upon exercise of
such warrants and minimum number of warrants that are
exercisable;
|
|
·
|
the
currency or currency units in which the offering price, if any, and the
exercise price are payable;
|
|
·
|
the
number of securities, if any, with which such warrants are being offered
and the number of such warrants being offered with each
security;
|
|
·
|
the
date on and after which such warrants and the related securities, if any,
will be transferrable separately;
|
|
·
|
the
amount of securities purchasable upon exercise of each warrant and the
price at which the securities may be purchased upon such exercise, and
events or conditions under which the amount of securities may be subject
to adjustment;
|
|
·
|
the
date on which the right to exercise such warrants shall commence and the
date on which such right shall
expire;
|
|
·
|
the
circumstances, if any, which will cause the warrants to be deemed to be
automatically exercised;
|
|
·
|
any
material risk factors, if any, relating to such
warrants;
|
|
·
|
the
identity of any warrant agent; and
|
|
·
|
any
other terms of such warrants (which shall not be inconsistent with the
provisions of the warrant
agreement).
|
The terms
of the warrants that we offer may or may not have the same material terms as our
currently outstanding warrants.
Prior to
the exercise of any warrants, holders of such warrants will not have any rights
of holders of the securities purchasable upon such exercise, including the right
to receive payments of dividends, if any, on the securities purchasable upon
such exercise, statutory appraisal rights or the right to vote such underlying
securities. Prospective purchasers of warrants should be aware that material
U.S. federal income tax, accounting and other considerations may be applicable
to instruments such as warrants.
DESCRIPTION
OF UNITS
We may
issue units comprised of one or more of the other securities described in this
prospectus in any combination. Each unit will be issued so that the holder
of the unit is also the holder of each security included in the unit. Thus, the
holder of a unit will have the rights and obligations of a holder of each
included security. A unit agreement under which a unit is issued may
provide that the securities included in the unit may not be held or transferred
separately, at any time or at any time before a specified date.
The
applicable prospectus supplement may describe:
|
·
|
the
designation and terms of the units and of the securities comprising the
units, including whether and under what circumstances those securities may
be held or transferred separately;
|
|
·
|
any
provisions for the issuance, payment, settlement, transfer or exchange of
the units or of the securities comprising the units;
and
|
|
·
|
any
additional terms of the governing unit
agreement.
|
The
applicable prospectus supplement will describe the terms of any units. The
preceding description and any description of units in the applicable prospectus
supplement does not purport to be complete and is subject to and is qualified in
its entirety by reference to the unit agreement and, if applicable, collateral
arrangements and depositary arrangements relating to such units.
ANTI-TAKEOVER
CHARTER PROVISIONS AND LAWS
Some
features of our certificate of incorporation and by-laws and the Delaware
General Corporation Law (DGCL), which are further described below, may have the
effect of deterring third parties from making takeover bids for control of our
company or may be used to hinder or delay a takeover bid. This would decrease
the chance that our stockholders would realize a premium over market price for
their shares of common stock as a result of a takeover bid. See Risk
Factors.
Limitations
on Stockholder Actions
Our
certificate of incorporation provides that stockholder action may only be taken
at a meeting of the stockholders. Thus, an owner of a majority of the voting
power could not take action to replace the board of directors, or any class of
directors, without a meeting of the stockholders, nor could he amend the by-laws
without presenting the amendment to a meeting of the stockholders. Furthermore,
under the provisions of the certificate of incorporation and by-laws, only the
board of directors has the power to call a special meeting of stockholders.
Therefore, a stockholder, even one who owns a majority of the voting power, may
neither replace sitting board of directors members nor amend the by-laws before
the next annual meeting of stockholders.
Advance
Notice Provisions
Our
by-laws establish advance notice procedures for the nomination of candidates for
election as directors by stockholders, as well as for other stockholder
proposals to be considered at annual meetings. Generally, we must receive a
notice of intent to nominate a director or raise any other matter at a
stockholder meeting not less than 120 days before the first anniversary of the
mailing of our proxy statement for the previous year’s annual meeting. The
notice must contain required information concerning the person to be nominated
or the matters to be brought before the meeting and concerning the stockholder
submitting the proposal.
Delaware
Law
We are
incorporated in Delaware, and as such are subject to Section 203 of the DGCL,
which provides that a corporation may not engage in any business combination
with an interested stockholder during the three years after he becomes an
interested stockholder unless:
•
the corporation’s board of directors approved
in advance either the business combination or the transaction which resulted in
the stockholder becoming an interested stockholder;
•
the interested stockholder owned at least 85
percent of the corporation’s voting stock at the time the transaction commenced;
or
•
the business combination is approved by the
corporation’s board of directors and the affirmative vote of at least two-thirds
of the voting stock which is not owned by the interested
stockholder.
An
interested stockholder is anyone who owns 15 percent or more of a corporation’s
voting stock, or who is an affiliate or associate of the corporation and was the
owner of 15 percent or more of the corporation’s voting stock at any time within
the previous three years; and the affiliates and associates of any those
persons. Section 203 of the DGCL makes it more difficult for an interested
stockholder to implement various business combinations with our Company for a
three-year period, although our stockholders may vote to exclude it from the
law’s restrictions.
Classified
Board
Our
certificate of incorporation and by-laws divide our board of directors into
three classes with staggered three year terms. There are currently eight
directors, two in one class and three in each of two additional classes. At each
annual meeting of stockholders, the terms of one class of directors will expire
and the newly nominated directors of that class will be elected for a term of
three years. The board of directors will be able to determine the total number
of directors constituting the full board of directors and the number of
directors in each class, but the total number of directors may not exceed 9 nor
may the number of directors in any class exceed six. Subject to these rules, the
classes of directors need not have equal numbers of members. No reduction in the
total number of directors or in the number of directors in a given class will
have the effect of removing a director from office or reducing the term of any
then sitting director. Stockholders may only remove directors for cause. If the
board of directors increases the number of directors in a class, it will be able
to fill the vacancies created for the full remaining term of a director in that
class even though the term may extend beyond the next annual meeting. The
directors will also be able to fill any other vacancies for the full remaining
term of the director whose death, resignation or removal caused the
vacancy.
A person
who has a majority of the voting power at a given meeting will not in any one
year be able to replace a majority of the directors since only one class of the
directors will stand for election in any one year. As a result, at least two
annual meeting elections will be required to change the majority of the
directors by the requisite vote of stockholders. The purpose of classifying the
board of directors is to provide for a continuing body, even in the face of a
person who accumulates a sufficient amount of voting power, whether by ownership
or proxy or a combination, to have a majority of the voting power at a given
meeting and who may seek to take control of our Company without paying a fair
premium for control to all of the owners of our common stock. This will allow
the board of directors time to negotiate with such a person and to protect the
interests of the other stockholders who may constitute a majority of the shares
not actually owned by that person. However, it may also have the effect of
deterring third parties from making takeover bids for control of our Company or
may be used to hinder or delay a takeover bid.
Transfer
Agent and Registrar
The transfer agent and registrar for
our common stock is Continental Stock Transfer & Trust Company, located in
New York, New York.
SELLING
STOCKHOLDERS
Under this prospectus and any
applicable supplements, the selling stockholder may sell shares of our common
stock. These shares may be acquired by the selling stockholder upon the
exercise of the Montaur Warrants, and/or upon conversion of outstanding shares
of our Series B Preferred Stock, which were issued in June 2010 in exchange for
the Montaur Notes and the Series A Preferred Stock. The selling stockholder may
also sell shares of common stock that were issued to them as interest on the
Montaur Notes prior to the June 2010 exchange, or as preferred dividends on the
Series A Preferred Stock prior to the June 2010 exchange. As used in this
prospectus, “selling stockholder” will refer to the selling stockholder along
with any pledgees, assignees, donees, transferees or successors in
interest.
The following table presents
information regarding the selling stockholder and the shares that may be sold by
it pursuant to this prospectus.
Selling
Stockholder
|
|
Shares
Owned
Before
Offering (1)
|
|
|
Percentage of
Outstanding
Shares Owned
Before Offering
(1)
|
|
|
Shares to
be Sold in
the
Offering
|
|
|
Percentage of
Outstanding
Shares Owned
After Offering (1)
|
|
Platinum-Montaur
Life Sciences, LLC (2)(3)
|
|
|
7,671,621 |
|
|
|
9.3 |
% |
|
|
15,000,000 |
|
|
|
9.3 |
% |
(1)
The ownership percentages listed in these columns include only shares
beneficially owned by the listed selling stockholder. Beneficial ownership is
determined in accordance with the rules of the Securities and Exchange
Commission. In computing the percentage of shares beneficially owned by a
selling stockholder, shares of common stock subject to warrants or preferred
stock convertible into common stock held by that selling stockholder that were
exercisable on or within 60 days after August 2, 2010, were deemed outstanding
for the purpose of computing the percentage ownership of that selling
stockholder. The ownership percentages are calculated assuming that 82,280,755
shares of common stock were outstanding on August 2, 2010. Of the 7,671,621
shares set forth in the table above, 7,463,985 are held by Platinum Partners
Value Arbitrage Fund, LP, a Cayman Island exempt partnership (“PPVAF”). PPVAF’s
address is 152 West 57th Street,
54th
Floor, New York, NY. None of the shares held by PPVAF are being offered
hereby.
(2)
Prior to giving effect to the offering, Platinum-Montaur Life Sciences,
LLC (“Montaur”), 152 W. 57th Street,
54th
Floor, New York, NY 10019, holds: (a) 10,000 shares of our Series B Preferred
Stock convertible into 32,700,000 shares of our common stock; and (b) warrants
to purchase 16,733,333 shares of our common stock. Each of our shares of
preferred stock and warrants held by Montaur provide that Montaur may not
convert any of the preferred stock, or exercise any of the warrants, to the
extent that such conversion or exercise would result in the holder and its
affiliates together beneficially owning more than 4.99% or 9.99% of the
outstanding shares of our common stock, except on 61 days’ prior written notice
to us that Montaur waives such limitation. Following the offering, assuming the
sale of all shares of our common stock offered hereby, Montaur will still hold
7,671,621 shares of our common stock.
(3)
Marc Nordlicht has the voting and dispositive power over the shares to be
sold in the offering. Mr. Nordlicht disclaims beneficial ownership of such
shares except to the extent of his pecuniary interest in the selling
stockholder.
For each sale of common stock by a
selling stockholder, we will file a prospectus supplement setting forth, with
respect to each selling stockholder:
|
·
|
the
name of the selling stockholder;
|
|
·
|
the
nature of any position, office or other material relationship which the
selling stockholder will have had during the prior three years with us or
any of our predecessors or
affiliates;
|
|
·
|
the
number of common shares owned by the selling stockholder prior to the
offering;
|
|
·
|
the
number of common shares to be offered for the selling stockholder’s
account; and
|
|
·
|
the
number of shares and (if one percent or more) the percentage of our common
shares to be owned by the selling stockholder after completion of the
offering.
|
PLAN
OF DISTRIBUTION
We and the selling stockholders may
sell the securities from time to time pursuant to underwritten public offerings,
negotiated transactions, block trades or a combination of these methods.
We and the selling stockholders may sell the securities separately or
together:
|
·
|
through
one or more underwriters or dealers in a public offering and sale by
them;
|
|
·
|
directly
to one or more purchasers.
|
The securities may be distributed from
time to time in one or more transactions:
|
·
|
at
a fixed price or prices, which may be
changed;
|
|
·
|
at
market prices prevailing at the time of
sale;
|
|
·
|
at
prices related to such prevailing market prices;
or
|
We or the selling stockholders may
solicit directly offers to purchase the securities being offered by this
prospectus, and may also designate agents to solicit offers to purchase the
securities from time to time. We will name in a prospectus supplement any
agent involved in the offer or sale of the securities.
If we utilize a dealer in the sale of
the securities being offered by this prospectus, we will sell the securities to
the dealer, as principal. The dealer may then resell the securities to the
public at varying prices to be determined by the dealer at the time of
resale.
If we or the selling stockholders
utilize an underwriter in the sale of the securities being offered by this
prospectus, we and/or the selling stockholders will execute an underwriting
agreement with the underwriter at the time of sale and we will provide the name
of any underwriter in the prospectus supplement that the underwriter will use to
make resales of the securities to the public. In connection with the
sale of the securities, we or the purchasers of securities for whom the
underwriter may act as agent may compensate the underwriter in the form of
underwriting discounts or commissions. The underwriter may sell the
securities to or through dealers, and the underwriter may compensate those
dealers in the form of discounts, concessions or commissions.
In
compliance with guidelines of the Financial Industry Regulatory Authority, or
FINRA, the maximum consideration or discount to be received by any FINRA member
or independent broker dealer may not exceed 8.0% of the aggregate amount of the
securities offered pursuant to this prospectus and any applicable prospectus
supplement.
We will provide in the applicable
prospectus supplement any compensation we will pay to underwriters, dealers or
agents in connection with the offering of the securities, and any discounts,
concessions or commissions allowed by underwriters to participating
dealers. Underwriters, dealers and agents participating in the
distribution of the securities may be deemed to be underwriters within the
meaning of the Securities Act of 1933, as amended, and any discounts and
commissions received by them and any profit realized by them on resale of the
securities may be deemed to be underwriting discounts and
commissions. We may enter into agreements to indemnify underwriters,
dealers and agents against civil liabilities, including liabilities under the
Securities Act or to contribute to payments they may be required to make in
respect thereof.
The securities may or may not be listed
on a national securities exchange. To facilitate the offering of
securities, certain persons participating in the offering may engage in
transactions that stabilize, maintain or otherwise affect the price of the
securities. This may include over-allotments or short sales of the
securities, which involves the sale by persons participating in the offering of
more securities than we sold to them. In these circumstances, these
persons would cover such over-allotments or short positions by making purchases
in the open market or by exercising their over-allotment option. In
addition, these persons may stabilize or maintain the price of the securities by
bidding for or purchasing securities in the open market or by imposing penalty
bids, whereby selling concessions allowed to dealers participating in the
offering may be reclaimed if securities sold by them are repurchased in
connection with stabilization transactions. The effect of these
transactions may be to stabilize or maintain the market price of the securities
at a level above that which might otherwise prevail in the open
market. These transactions may be discontinued at any
time.
We may enter into derivative
transactions with third parties, or sell securities not covered by this
prospectus to third parties in privately negotiated transactions. If
the applicable prospectus supplement indicates, in connection with any
derivative transaction, the third parties may sell securities covered by this
prospectus and the applicable prospectus supplement, including in short sale
transactions. If so, the third party may use securities pledged by us
or borrowed from us or others to settle those sales or to close out any related
open borrowings of stock, and may use securities received from us in settlement
of those derivatives to close out any related open borrowings of
stock. The third party in such sale transactions will be an
underwriter and, if not identified in this prospectus, will be identified in the
applicable prospectus supplement or a post-effective amendment to the
registration statement of which this prospectus is a part. In
addition, we may otherwise loan or pledge securities to a financial institution
or other third party that in turn may sell the securities short using this
prospectus. Such financial institution or other third party may
transfer its economic short position to investors in our securities or in
connection with a concurrent offering of other securities.
The selling stockholders may also sell
our common stock in one or more privately negotiated transactions exempt from
the registration requirements of the Securities Act pursuant to Rule 144 under
the Securities Act, Section 4(1) of the Securities Act or other applicable
exemptions, regardless of whether the securities are covered by the registration
statement of which this prospectus forms a part. Such sales, if any, will not
form part of the plan of distribution described in this prospectus. The selling
stockholders will act independently of us in making decisions with respect to
the timing, manner and size of each such sale.
The underwriters, dealers and agents
may engage in transactions with us, or perform services for us, in the ordinary
course of business.
LEGAL
MATTERS
The validity of the shares offered
hereby has been passed upon for us by Porter, Wright, Morris & Arthur LLP,
41 South High Street, Columbus, Ohio 43215.
EXPERTS
The financial statements as of December
31, 2009 and 2008 and for each of the years then ended incorporated by reference
in this Prospectus have been so incorporated in reliance on the report of BDO
Seidman, LLP, an independent registered public accounting firm, incorporated
herein by reference, given on the authority of said firm as experts in auditing
and accounting.
Neoprobe
Corporation
3,157,896
Shares of Common Stock
Series
CC Warrants to Purchase 1,578,948 Shares of Common Stock
Series
DD Warrants to Purchase 1,578,948 Shares of Common Stock
Prospectus
Supplement
November
7, 2010