0001168220-16-000148.txt : 20160222 0001168220-16-000148.hdr.sgml : 20160222 20160222155237 ACCESSION NUMBER: 0001168220-16-000148 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20160222 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160222 DATE AS OF CHANGE: 20160222 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ULURU Inc. CENTRAL INDEX KEY: 0001168220 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 412118656 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33618 FILM NUMBER: 161444959 BUSINESS ADDRESS: STREET 1: 4452 BELTWAY DRIVE CITY: ADDISON STATE: TX ZIP: 75001 BUSINESS PHONE: 214-905-5145 MAIL ADDRESS: STREET 1: 4452 BELTWAY DRIVE CITY: ADDISON STATE: TX ZIP: 75001 FORMER COMPANY: FORMER CONFORMED NAME: ULURU INC. DATE OF NAME CHANGE: 20060417 FORMER COMPANY: FORMER CONFORMED NAME: OXFORD VENTURES INC DATE OF NAME CHANGE: 20020225 8-K 1 form8k_022216.htm FORM 8-K FEBRUARY 22, 2016 form8k_022216.htm


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 22, 2016

 
ULURU Inc.
(Exact Name of Registrant as Specified in its Charter)


         
Nevada
 
000-49670
 
41-2118656
(State or Other Jurisdiction of
Incorporation)
 
(Commission File Number)
 
(I.R.S. Employer
Identification No.)
         


 
4452 Beltway Drive
Addison, Texas 75001
(Address of principal executive offices) (Zip Code)
 
Registrant’s telephone number, including area code: (214) 905-5145
 
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:
o
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


 
 

 


SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Information included in this Form 8-K may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).  This information may involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by any forward-looking statements.  Forward-looking statements, which involve assumptions and describe our future plans, strategies and expectations, are generally identifiable by use of the words “may,” “will,” “should,” “expect,” “anticipate,” “estimate,” “believe,”  “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology.  Forward-looking statements are based on assumptions that may be incorrect, and there can be no assurance that any projections or other expectations included in any forward-looking statements will come to pass.  Our actual results could differ materially from those expressed or implied by the forward-looking statements as a result of various factors including, but not limited to the risks that our liquidity issues will prevent or delay our ability to expand distribution into new markets or continue to actively market in existing markets; that we will not be able to achieve or expand revenues in newly licensed territories at the rate or level expected, or at all; that we will not be successful in registering and receiving regulatory authorizations in new territories at the rate or level expected, or at all; that we will experience manufacturing, shipping or other delays in product shipments in newly licensed territories; and that the launch of a bundled product offering will not provide clinical benefits on wound healing and will not achieve additional revenues; that our product development and approval efforts may be delayed due to our limited resources and those of our distribution affiliates; and that we may  become insolvent and, as a result, fail to execute our business plan or continue as a going concern.  In addition, factors and risks that may cause forward-looking statements to fail to come to pass are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014 and other reports filed by us with the Securities and Exchange Commission.  Except as required by applicable laws, we undertake no obligation to update publicly any forward-looking statements for any reason, even if new information becomes available or other events occur in the future.


Item 7.01
Regulation FD Disclosure

On February 22, 2016, ULURU Inc. (the “Company”) issued a press release to provide an update on the Company’s recent business activities

The information set forth in this Item 7.01, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.


Item 8.01
Other Event

Item 7.01 is incorporated herein by this reference.

 
Item 9.01
Financial Statements and Exhibits
   
(d)
Exhibits
   
Exhibit No.
 
Description
 

 
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.

 
ULURU Inc.
   
Date: February 22, 2016
 
By:
/s/ Terrance K. Wallberg
 
   
Terrance K. Wallberg
   
Vice President and Chief Financial Officer
 

 

 
 

 

EX-99.1 2 ex_99-1.htm PRESS RELEASE DATED FEBRUARY 22, 2016 ex_99-1.htm


 
ULURU NEWS

Contact: Company
Helmut Kerschbaumer
Interim President & CEO

Terrance K. Wallberg
Vice President & CFO
(214) 905-5145


ULURU INC. PROVIDES UPDATE ON

RECENT BUSINESS ACTIVITIES – FEBRUARY 2016


Addison, Texas, February 22, 2016; ULURU Inc. (OTCQB: ULUR), a specialty pharmaceutical company focused on the development of a portfolio of wound management and oral care products to provide improved clinical outcomes through controlled delivery utilizing its innovative Nanoflex® Aggregate technology and OraDisc™ transmucosal delivery system, is pleased to provide an update on the Company’s corporate and business operational activities.

Management and Board of Directors

On November 19, 2015, the ULURU Inc. (the “Company”) appointed Helmut Kerschbaumer to serve as the Company’s interim President and Chief Executive Officer.  Mr. Kerschbaumer currently serves a Director of the Company and is also the executive director of Altrazeal AG, the international distributor of Altrazeal®, our wound care product.  Also occurring on November 19, 2015, was the appointment of Bradley J. Sacks to serve as the Chairman of the Board of Directors of the Company.  Mr. Sacks has served as a Director of the Company since July 2015.  On November 19, 2015, Mr. Gray resigned as the Company’s President and Chief Executive Officer and on February 18, 2016 resigned as a Director for the Company.  Effective as of December 1, 2015, Jeffrey Davis also resigned as a Director of the Company.

Acquisition of Certain Marketing and Distribution Rights

On December 24, 2015, the Company acquired the marketing and distribution rights for Altrazeal® from Altrazeal Trading GmbH and IPMD GmbH for the certain territories to include the European Union, the Middle East, Australia, New Zealand, North Africa, and the Balkan States.  As a result of these acquisitions, the Company has a direct relationship with each local distributor.

Expanded Distribution Network

We recently received notice from Altrazeal AG, a distribution partner for the Company, that it had entered into an exclusive agreement for the marketing and distribution of Altrazeal® across various countries in Latin America.  The agreement provides the licensee, a regional distributor with a presence in each of Venezuela, Peru, Chile, Colombia, and Costa Rica, with rights to distribute Altrazeal® in these countries in Latin America.  Registration of Altrazeal® in each of these markets will begin shortly and it is anticipated that product shipments will commence in the near term.

Altrazeal AG has also entered into an exclusive agreement for the marketing and distribution of Altrazeal® in Kenya, Tanzania, Ruanda, and Uganda.

Industry Exposure

Al Hikma FZCO, our distribution partner for the Middle East, exhibited Altrazeal® at the 2016 Arab Health Exhibition & Congress (“Arab Health”) held in Dubai on January 25 – 28, 2016.  Arab Health is the largest healthcare exhibition & medical congress in the Middle East and second largest in the world.  We anticipate the Middle East to become an important region as Altrazeal® is under registration in more than eight markets and regulatory authorizations for these markets are anticipated in the second quarter of 2016.

Al Hikma FZCO is also scheduled to showcase Altrazeal® at the Third Khorfakkan International Surgical Congress to be held in Oman on February 27 - 28, 2016.  An estimated 800 doctors and nurses from more than 12 countries are expected to participate in the conference.

 
 

 
 
Scientific Publications and Presentations

Clarity Healthcare, the Company’s distribution partner in Spain, recently exhibited Altrazeal® at the Spanish Wound Management Congress that was held February 5-7, 2016.  Altrazeal® was showcased through six poster presentations and a scientific publication within the official journal of the Spanish Wound Management Society highlighting the clinical and economical benefits of wound treatments, including Altrazeal®.

Expanded Product Offering

In the second quarter of 2016, the Company plans to launch its first bundled product offering in Germany.  The bundled package will consist of Altrazeal® 0.75g blisters and a hypochlorite hydrogel, the combination of which has shown synergistic clinical effects on the wound healing process. This convenient package will further support the increased usage of Altrazeal® in Germany.
 
Corporate Overview

We are currently in discussions with various investors from both Europe and the U.S. as a result of meetings and presentations we attended around the JP Morgan Healthcare Conference that was held in San Francisco, California in January 2016.

In September 2015, we entered into a Securities Purchase Agreement with several institutional investors relating to an equity investment of $1,588,225 by the Investors for 4,179,539 shares of our common stock, at a per-share purchase price of $0.38.  We have received net proceeds of approximately $1,257,000, of which approximately $1,050,000 was received in October 2015 and $207,000 was received in November 2015.

We recently updated our corporate website with our latest investor presentation, which is now available at http://uluruinc.com/presentations/Uluru_Investor_Presentation_2016-02-08.pdf.



About ULURU Inc.:

ULURU Inc. is a specialty pharmaceutical company focused on the development of a portfolio of wound management and oral care products to provide patients and consumers improved clinical outcomes through controlled delivery utilizing its innovative Nanoflex® Aggregate technology and OraDisc™ transmucosal delivery system.  For further information about ULURU Inc., please visit our website at www.uluruinc.com.  For further information about Altrazeal®, please visit www.Altrazeal.com.

ULURU Inc. (OTCQB: ULUR) trades on the OTCQB Venture stage marketplace for early stage and developing U.S. and international companies. Companies are current in their reporting and undergo an annual verification and management certification process. Investors can find Real-Time quotes and market information for the company on www.otcmarkets.com.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended.  These statements are subject to numerous risks and uncertainties, including but not limited to the risk that we will not be able to successfully manage the distribution relationships it has, that we will not be able to achieve or expand revenues in newly licensed territories, that we will be successful in registering and receiving regulatory authorizations in new territories, the timing of product shipments in newly licensed territories, the launch of a bundled product offering will not provide clinical benefits on wound healing, a bundled product will not achieve additional revenues and the risk factors detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, and other reports filed by us with the Securities and Exchange Commission.