UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) February 24, 2005
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NEOPROBE CORPORATION
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(Exact name of registrant as specified in its charter)
Delaware 0-26520 31-1080091
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Identification No.)
425 Metro Place North, Suite 300, Columbus, Ohio 43017
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (614) 793-7500
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(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
|_| Written communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
|_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
|_| Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
|_| Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition.
On February 24, 2005, Neoprobe Corporation (the "Company") issued a press
release regarding its consolidated financial results for the fourth quarter and
for the full year ended December 31, 2004. A copy of the Company's press release
is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is
incorporated herein by reference.
The information contained in Item 2.02 of this Current Report on Form 8-K,
including the exhibit 99.1 hereto, shall not be treated as "filed" for purposes
of the Securities Exchange Act of 1934, as amended.
Statements contained or incorporated by reference in this Current Report
on Form 8-K which relate to other than strictly historical facts, such as
statements about the Company's plans and strategies, expectations for future
financial performance, new and existing products and technologies, and markets
for the Company's products, are forward-looking statements. The words "believe,"
"expect," "anticipate," "estimate," "project," and similar expressions identify
forward-looking statements that speak only as of the date hereof. Investors are
cautioned that such statements involve risks and uncertainties that could cause
actual results to differ materially from historical or anticipated results due
to many factors including, but not limited to, the Company's continuing
operating losses, uncertainty of market acceptance, reliance on third party
manufacturers, accumulated deficit, future capital needs, uncertainty of capital
funding, dependence on limited product line and distribution channels,
competition, limited marketing and manufacturing experience, and other risks
detailed in the Company's most recent Annual Report on Form 10-KSB and other
Securities and Exchange Commission filings. The Company undertakes no obligation
to publicly update or revise any forward-looking statements.
Item 8.01. Other Events.
On February 24, 2005, the Company issued a press release announcing that
the U.S. Food and Drug Administration (FDA) has accepted its request to
establish a corporate Investigational New Drug (IND) application for
Lymphoseek(TM). A copy of the Company's press release is furnished as Exhibit
99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
With the establishment of the corporate IND, responsibility for the clinical and
commercial development of Lymphoseek has been officially transferred from the
University of California, San Diego (UCSD) to Neoprobe. Lymphoseek is intended
to be used in biopsy procedures for the detection of lymph nodes in a variety of
tumor types including breast, melanoma, prostate, gastric and colon cancers.
In connection with the transfer of responsibility for the Lymphoseek IND
from UCSD to Neoprobe, FDA has provided guidance suggesting Lymphoseek be
evaluated in a multi-center clinical study to confirm the findings observed by
the UCSD researchers. This initial multi-center trial would then be followed by
a confirmatory Phase III study using the final cGMP material. Neoprobe intends
to commence enrollment in the first of the two multi-institutional studies as
soon as the appropriate regulatory and institutional review board clearances are
received. These multi-center studies are planned to be conducted at some of the
leading cancer treatment institutions in the world. FDA guidelines also require
Neoprobe to complete some additional preclinical activities prior to the
initiation of the multi-center trials. Neoprobe has initiated this preclinical
work in parallel to its other development activities and intends to submit an
IND amendment prior to the initiation of the multi-center studies.
Item 9.01 Financial Statements and Exhibits.
(c) Exhibits.
Exhibit
Number Exhibit Description
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99.1 Neoprobe Corporation press release dated February 24, 2005, entitled
"Neoprobe Announces 2004 Annual Results."
99.2 Neoprobe Corporation press release dated February 24, 2005, entitled
"Neoprobe Establishes Corporate IND for Lymphoseek."
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Neoprobe Corporation
Date: February 28, 2005 By: /s/ Brent L. Larson
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Brent L. Larson, Vice President Finance
and Chief Financial Officer