UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
DC 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) |
September 11, 2014 |
CYTOCORE, INC.
(Exact Name of Registrant as Specified in
Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
333-143570 |
36-4296006 |
(Commission File Number) |
(IRS Employer Identification No.) |
4203 SW 34th St. |
|
Orlando, FL |
32811 |
(Address of Principal Executive Offices) |
(Zip Code) |
(407)
996-9631
(Registrant’s telephone number, including
area code)
(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):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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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 7.01 Regulation FD Disclosure.
On September 11, 2014,
Cytocore, Inc. (the “Company”) issued a letter to its shareholders updating the Company’s recent progress and
developments since its Letter to Shareholders dated July 7, 2014. A copy of the letter to
shareholders is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference. The Company
does not undertake to update this presentation.
The information contained
in this Item 7.01 of this Current Report on Form 8-K and in the accompanying exhibit incorporated by reference herein shall not
be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general
incorporation language in such filing, unless expressly incorporated by specific reference to such filing. This information, including
the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of
1934, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933.
The information set
forth in this Current Report on Form 8-K and the attached Exhibit 99.1, includes "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, regarding future operating performance, events, trends and plans. All statements other than statements of historical fact
contained herein, including, without limitation, statements regarding our future financial position, business strategy, budgets,
projected revenues and costs, and plans and objectives of management for future operations, are forward-looking statements. Forward-looking
statements generally can be identified by the use of forward-looking terminology such as “may,” “will,”
“expects,” “intends,” “plans,” “projects,” “estimates,” “anticipates,”
or “believes” or the negative thereof or any variation thereon or similar terminology or expressions. We have based
these forward-looking statements on our current expectations and projections about future events. These forward-looking statements
are not guarantees and are subject to known and unknown risks, uncertainties and assumptions about us that may cause our actual
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. Important factors that could cause our actual
results to differ from our expectations, include but are not limited to, MEDITE’s ability following the acquisition to maintain
and grow its revenues, our ability to integrate MEDITE’s operations with our historic operations, the effect that the acquisition
will have on MEDITE’s existing customers and employees, our ability to protect our intellectual property rights, as well
as those risk factors that apply to our operations as disclosed in Item 1A of Cytocore’s Annual Report on Form 10-K for the
year ended December 31, 2013 and other filings with the Securities and Exchange Commission. Readers are cautioned not to place
undue reliance on our forward-looking statements, as they speak only as of the date made. Such statements are not guarantees of
future performance or events and we undertake no obligation to disclose any revision to these forward-looking statements to reflect
events or circumstances occurring after the date hereof.
Item 9.01 Financial Statements and
Exhibits.
Exhibit 99.1. Shareholder
Letter dated September 11, 2014
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.
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CYTOCORE, INC. |
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Date: September 11, 2014 |
By: |
/s/ Michaela Ott |
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Michaela Ott |
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Chief Executive Officer |
EXHIBIT 99.1
Shareholder Letter
September 11, 2014
To Our Shareholders and Friends,
As we shared with you several months ago,
the first half of 2014 was a period of significant progress for the Company as we completed the merger with CytoCore and successfully
integrated the two businesses. Today we are operating as one Company with clear objectives - grow the MEDITE business, guide the
development of CytoCore’s technology in the form of marketable products and generate synergies between both of these complimentary
product lines to increase our position in the market. As a single entity we have already achieved some early successes which has
resulted in significant revenue growth and increased profitability in the first six months of 2014. In addition, we reduced our
cost basis and raised $1.8 million to strengthen our financial position. We are well on our way of becoming a rapidly growing and
disruptive force in the multi-billion dollar global anatomic pathology and cytology systems marketplace for cancer detection.
For the first six months of 2014 we reported
record revenue of $5.9 million, a 32% increase compared to the 2013 first half revenue of $4.5 million. The strong growth was driven
by newly launched cytology products and the new distribution contracts which allow us to substantially increase our presence in
the market. We also delivered an operating profit that rose to $490,000 compared with the first half 2013 operating profit of $120,000.
With a solid first half of the year behind us, we are well positioned for accelerated growth in the second half. Historically,
the second half has outperformed the first half and based on several recent developments, we expect our core business to demonstrate
steady progress strengthening our outlook for the remainder of the year.
These recent developments include:
| · | We received the first registration confirmation of Chinese FDA for our Microtome models M530 and
A550. Our Chinese Joint Venture partner, UNIC, is working on the registration for the remaining products and is placing additional
orders for equipment purchases. China has a shortage of pathologists and cytologists and our systems are well suited to meet the
country’s expanding needs – 500 new labs annually – so this represents a significant growth opportunity for the
Company. |
| · | We were recently awarded a Premier group purchasing agreement as vendor for the next three years.
This gives us access to the nation’s largest healthcare alliance serving over 2,500 hospitals and 80,000-plus other healthcare
sites representing more than $43 billion in annual purchasing power. |
| · | We established an R&D facility in Poland to complement our German manufacturing facility. We
plan to employ mechanical, electronic and software engineers and the first major objective is to finish the breast cancer risk
evaluation device. MEDITE is also building up this facility as a distribution centre for the lucrative Polish market, which has
a population exceeding 50 million. |
| · | We executed another non-exclusive distribution contract for the North American market with a large
and well established multi-billion USD distribution company for health care products. The contract includes our anatomic pathology
equipment and consumable line. |
Also, the greater awareness of the MEDITE
name – which has now risen to number three in brand recognition in the fast growing China market - as well our products is
driving increased market interest. At two recent industry events, the Histology Convention in Austin, TX and the European Congress
of Pathology held in London, we drew larger crowds at our booths compared to previous years reflecting stronger demand for our
products and new revenue opportunities for our Company.
In summary, we have generated strong financial
results and are excited about the second half given the market’s positive acceptance of our new products.
Thank you for your continued support!
Respectfully,
/s/Michaela Ott |
/s/Robert McCullough |
/s/Michael Ott |
Chief Executive Officer |
Chief Financial Officer |
President and Chief Operating Officer |
This letter to shareholders contains
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, regarding future operating performance, events, trends and plans. All statements other than statements
of historical fact contained herein, including, without limitation, statements regarding our future financial position, business
strategy, budgets, projected revenues and costs, and plans and objectives of management for future operations, are forward-looking
statements. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may,”
“will,” “expects,” “intends,” “plans,” “projects,” “estimates,”
“anticipates,” or “believes” or the negative thereof or any variation thereon or similar terminology or
expressions. We have based these forward-looking statements on our current expectations and projections about future events. These
forward-looking statements are not guarantees and are subject to known and unknown risks, uncertainties and assumptions about us
that may cause our actual 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. Important factors that
could cause our actual results to differ from our expectations, include but are not limited to, MEDITE’s ability following
the acquisition to maintain and grow its revenues, our ability to integrate MEDITE’s operations with our historic operations,
the effect that the acquisition will have on MEDITE’s existing customers and employees, our ability to protect our intellectual
property rights, as well as those risk factors that apply to our operations as disclosed in Item 1A of CytoCore’s Annual
Report on Form 10-K for the year ended December 31, 2013, Form 10-Q filed on August 19, 2014 and other filings with the Securities
and Exchange Commission. Readers are cautioned not to place undue reliance on our forward-looking statements, as they speak only
as of the date made. Such statements are not guarantees of future performance or events and we undertake no obligation to disclose
any revision to these forward-looking statements to reflect events or circumstances occurring after the date hereof.
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