0001354488-14-002288.txt : 20140507 0001354488-14-002288.hdr.sgml : 20140507 20140507083726 ACCESSION NUMBER: 0001354488-14-002288 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20140501 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140507 DATE AS OF CHANGE: 20140507 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TNI BIOTECH, INC. CENTRAL INDEX KEY: 0001559356 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 593226705 STATE OF INCORPORATION: FL FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-54933 FILM NUMBER: 14818960 BUSINESS ADDRESS: STREET 1: 618 EAST SOUTH STREET STREET 2: SUITE 500 CITY: ORLANDO STATE: FL ZIP: 32801 BUSINESS PHONE: 407-680-3097 MAIL ADDRESS: STREET 1: 618 EAST SOUTH STREET STREET 2: SUITE 500 CITY: ORLANDO STATE: FL ZIP: 32801 8-K 1 tnib_8k.htm CURRENT REPORT tnib_8k.htm


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549


FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934


Date of Report (Date of earliest event reported):  May 1, 2014


    TNI BIOTECH, INC.

(Exact name of registrant as specified in its charter)


Florida
000-54933
59-3226705
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)


618 East South Street, Suite 500
Orlando, Florida
32801
(Address of principal executive offices)
(Zip Code)


Registrant’s telephone number, including area code:  (888) 613-8802
 
Not Applicable
 (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 to 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))
 


 
 
 
 
 
 
Item 8.01.                      Other Events.

On May 1, 2014, TNI Biotech, Inc. (the “Company”) issued a press release announcing the approval by its board of directors to spin-off its wholly-owned subsidiary, Cytocom, Inc.  A copy of the press release is attached hereto as Exhibit 99.1.

On May 6, 2014, the Company issued a press release announcing regulatory approval of the marketing and sale of its proprietary drug, Low Dose Naltrexone (“LDN”) in Malawi. LDN obtained approval on April 16, 2014 from the Malawi Pharmacy, Medicines and Poisons Board, the drug regulatory authority of the government of Malawi. A copy of the press release is attached hereto as Exhibit 99.2.

ITEM 9.01.              Financial Statements and Exhibits.

(c)           Exhibits
 
 99.1   Press Release, dated May 1, 2014.
   
99.2    Press Release, dated May 6, 2014
          
 
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 SIGNATURE


     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.

   TNI BIOTECH, INC.  
       
Dated:   May 6, 2014 
By:
/s/ Noreen Griffin  
    Name: Noreen Griffin  
    Title:   Chief Executive Officer  
       


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EX-99.1 2 tnib_ex991.htm PRESS RELEASE tnib_ex991.htm
Exhibit 99.1
 
TNI BioTech, Inc. Announces Proposed Spin-Off of Cytocom, Inc.
 
Spin-off Would Allow Cytocom to Operate as a Separate Biotechnology Company Focused on Development of LDN and MENK Immunotherapy Products
 
TNI BioTech to Continue its Focus on International Manufacturing, Marketing and Distribution of LDN and MENK Immunotherapies
 
ORLANDO, May 1, 2014— TNI BioTech, Inc. (OTCQB:TNIB) (“TNIB” or the “Company”), a biopharmaceutical company focused on the development, marketing and distribution of opioid-related immunotherapies, announced that its board of directors has approved a plan to spin off its wholly-owned subsidiary, Cytocom Inc. (“Cytocom”), an entity established to operate TNIB’s drug development business.

Following the spin-off, Cytocom will initially focus on developing low dose naltrexone (“LDN”) and methionine-enkephalin (“MENK”) (the “Drug Development Business”). TNIB will continue to retain rights to certain assets, and will focus manufacturing, distribution and marketing of these LDN and MENK therapies of both human and animals in certain territories (the “Marketing and Distribution Business”).

To affect the spin-off “distribution” (hereinafter, sometimes referred to as the “Distribution”), TNIB will first undertake certain internal reorganizational steps, following which Cytocom will hold the Drug Development Business subject to certain terms and conditions.  At the time of the Distribution, each TNIB stockholder will receive one common share of Cytocom common stock for every one share of TNIB common stock held by such TNIB stockholder as of 5:00 p.m., Eastern Time, on July 15, 2014, which is therecord datefor the Distribution.  However, to the extent that a TNIB stockholder sells a portion or all of that stockholder’s shares of TNIB common stock prior to the record date, such stockholder also will be pro-rata selling the right to receive common shares of Cytocom through the Distribution.  TNIB stockholders need not pay any consideration to participate in the Distribution; however, mandatory surrender of existing TNIB shares will be required to receive shares of Cytocom through the Distribution. TNIB shareholders as of the record date will continue to own shares in TNIB in the same form and in the same quantity as of the record date.

TNIB will continue to be quoted on the OTCQB Market after the Distribution is completed and will continue to trade under the symbol “TNIB”.  Cytocom will be a reporting company under the Securities Exchange Act of 1934, as amended, by the time of the Distribution, but will not initially be quoted on any securities marketplace or exchange.
        
TNIB’s board of directors has determined that a strategic separation of TNIB’s two businesses is in the best interests of the TNIB stockholders. The Company believes that spinning off the Drug Development Business will provide several opportunities and benefits, including the following:

  
Market Recognition:  The investment community, including analysts, stockholders and prospective investors in each company, will be better able to realize the value of TNIB and Cytocom fully and independently and enhance the market recognition of each company;

  
Business Focus:  Each of TNIB and Cytocom will each be better able to focus efforts on and allocate resources towards its own business opportunities and challenges;

  
Improved Capital Flexibility:  TNIB and Cytocom will be able to deploy capital and access additional financing, if appropriate, in accordance with each company’s particular needs and business model; and

  
Employee Incentives:  Each of TNIB and Cytocom will be better able to attract, retain and motivate employees by providing equity compensation tied more directly to its performance.

The Distribution does not require TNIB stockholder approval.  An information statement containing details regarding the Distribution and Cytocom’s proposed business and management will be mailed to TNIB stockholders prior to the Distribution. The consummation of the Distribution is subject to the effectiveness of a Form 10 registration statement filed by Cytocom and the satisfaction or waiver of certain conditions that will be described in the information statement.

 
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“We believe separating these distinct businesses will allow each company to better pursue its long-term strategic initiatives and compete more effectively in its respective market,” said Noreen Griffin, CEO of TNIB. “We are confident this move is in the best interests of both companies and their respective stakeholders.”

Dr. Graham Burton, Cytocom’s Chief Executive Officer, commented, “I am excited about this transaction and look forward to serving as Cytocom’s Chief Executive Officer. There are many attractive development opportunities for LDN and MENK.  Cytocom’s Chief Operating Officer and Chief Financial Officer, Gary Gemignani, and I, are dedicated to putting the right management team in place to successfully execute Cytocom’s development strategy.”
  
Supplemental Materials and Website
 
Supplemental information on the transaction is available at  www.tnibiotech.com/investor-relations.  This press release has also been furnished to the SEC in a current report on Form 8-K.
 
TNIB routinely posts important information online on TNIB’s website, www.tnibiotech.com/investor-relations. TNIB uses this website, press releases, SEC filings, and webcasts to disclose material, non-public information in accordance with Regulation FD. TNIB encourages members of the investment community to monitor these distribution channels for material disclosures. Any information accessed through TNIB’s website is not incorporated by reference into, and is not a part of, this document.
 
Cautionary Note Regarding Forward-Looking Statements
 
This document includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about the plans, objectives, expectations and intentions of TNIB, including the benefits of the proposed spin-off of Cytocom from TNIB, and other statements that are not historical facts. These statements are based on the current expectations and beliefs of TNIB’s management and are subject to uncertainty and changes in circumstances. TNIB cautions readers that any forward-looking information is not a guarantee of future performance and that actual results may vary materially from those expressed or implied by the statements herein due to the conditions to the consummation of the proposed spin-off of Cytocom from TNIB, and changes in economic, business, competitive, technological, strategic and/or regulatory factors, as well as other factors affecting the operation of the other businesses of TNIB and Cytocom’s business. More detailed information about these factors may be found in filings by TNIB with the SEC, including its most recent Annual Report on Form 10-K in the sections entitled “Caution Concerning Forward-Looking Statements” and “Risk Factors.” Various other factors could cause actual results to differ from those set forth in the forward-looking statements, including, without limitation, the risk that the anticipated benefits from the proposed spin-off may not be fully realized or may take longer to realize than expected. TNIB is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events, or otherwise.


 
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About TNI BioTech Inc.

TNI BioTech, Inc. is a biopharmaceutical company involved in manufacturing, distribution, and marketing of our rights to our immunotherapy. Our products and immunotherapy technologies are designed to harness the power of the immune system in fighting chronic and life threatening disease. Our goal is to provide affordable sustainable health care in emerging nations where little or no treatments exist for many of these diseases.

Our, therapies have been shown in clinical trials to stimulate the immune system in patients with cancer, autoimmune diseases such as rheumatoid arthritis and multiple sclerosis, fibromyalgia, melanoma, prostate cancer, cervical cancer and inflammatory bowel disease. The therapies may be used as an adjunct in cancer patients undergoing chemotherapy, radiation treatments or surgery and in combination with antibiotics or retroviral drug therapy in the treatment of a variety of infectious diseases, including patients with HIV/AIDS.

About Cytocom Inc.
 
Cytocom, Inc. is a biotechnology company that will initially focus on developing LDN and MENK, in the investigation of unmet medical needs in the areas of oncology and inflammatory disease.

Contact:
Dennis S. Dobson
203-258-0159
 
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EX-99.2 3 tnib_ex992.htm PRESS RELEASE tnib_ex992.htm
Exhibit 99.2
 
TNI BioTech, Inc. Obtains Drug Approval For Sale of Low Dose Naltrexone (LDN) From Government of Malawi
 
ORLANDO, Fla., May 6, 2014  -- TNI BioTech, Inc. (otcqb:TNIB) ("TNI BioTech"), a biotechnology company focused on the development, marketing and distribution of opioid-related immunotherapies, today announced that effective as of April 16, 2014, it has successfully obtained approval from the Government of Malawi's drug regulatory authority, the Malawi Pharmacy, Medicines and Poisons Board, for the marketing and sale of Low Dose Naltrexone (LDN) in Malawi for the treatment of patients with cancer.
 
"The Government of Malawi's approval of LDN, to be distributed under the trade name Lodonal™, represents a monumental and historical achievement for TNI BioTech and was not possible without the support of the medical community in Malawi, which by this step and our collective ongoing work recognizes the importance of the treatment of cancer. TNI BioTech is grateful to the many people whose tireless efforts have made this day possible. This is an important milestone as we seek approval for sale of LDN in additional emerging nations and hope to bring our drug therapies to those in need worldwide," said Noreen Griffin, Chief Executive Officer of TNI BioTech.
 
Dr. Ndiouga Dieng, Vice President, African Affairs for TNI BioTech, said, "The approval of LDN by the Malawi Pharmacy, Medicines and Poisons Board will allow TNI BioTech to deliver on its commitment to sustainable healthcare to Africa. This significant achievement would not be possible without the vision of President Joyce Banda of Malawi and the dedication of Doctor Leo Masamba, Clinical Oncologist of Queen Elizabeth Hospital." TNI BioTech expects to begin delivery of Lodonal™ to Malawi within two weeks. The product license enables TNI BioTech to market Lodonal™ in Malawi until June 30, 2015, and is subject to annual renewal thereafter.  
 
Dr. Joseph Fortunak, Vice President, Drug Development and Quality Control at TNI BioTech said, "We are thrilled to be part of the effort to make this medicine available in Malawi and look forward to bringing LDN to other nations in Africa in the coming months."
 
"The approval of LDN by the Malawi Pharmacy, Medicines and Poisons Board offers hope especially to millions of women and girls in Malawi of a bright future in their effective management of HIV and AIDS, cervical, breast and other cancers, the deadly plagues that inhibit social and economic development and women's progress in Malawi. I commend TNI BioTech for leading the way in developing affordable, innovative immunotherapies such as LDN for combating diseases and improving health in Africa," stated His Excellency Steve Matenje, Malawi Ambassador to the United States of America.
 
The Malawi Pharmacy, Medicines and Poisons Board is a Malawi government agency under the Federal Ministry of Health that is responsible for regulating and controlling the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, chemicals and packaged water.
 
 
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About TNI BioTech, Inc.
 
TNI BioTech, Inc. is a biopharmaceutical company involved in manufacturing, distribution, and marketing of our rights to our immunotherapy. Our products and immunotherapy technologies are designed to harness the power of the immune system in fighting chronic and life threatening diseases. Our goal is to provide affordable sustainable health care in emerging nations where little or no treatments exist for many of these diseases.
 
TNI BioTech's therapies have been shown in clinical trials to stimulate the immune system in patients with cancer, autoimmune diseases such as rheumatoid arthritis and multiple sclerosis, fibromyalgia, melanoma, prostate cancer, cervical cancer, and inflammatory bowel disease.  The therapies may be used as an adjunct in cancer patients undergoing chemotherapy, radiation treatments or surgery and in combination with antibiotics or retroviral drug therapy in the treatment of a variety of infectious diseases, including the treatment of patients with HIV/AIDS.
 
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS: This press release includes various "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, which represent the Company's expectations or beliefs concerning future events. Statements containing expressions such as "plan," "project," "potential," "seek," "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" used in the Company's press releases and in Disclosure Statements and Reports filed with the Over The Counter Markets through the OTC Disclosure and News Service are intended to identify forward-looking statements. All forward-looking statements involve risks and uncertainties. Although TNI BioTech believes its expectations are based upon reasonable assumptions within the bounds of its knowledge of its business and operations, there can be no assurances that actual results will not differ materially from expected results. TNI BioTech cautions that these and similar statements included in this press release are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date thereof. TNI BioTech undertakes no obligation to publicly release any revisions to such forward-looking statements to reflect events or circumstances after the date hereof, except as required by applicable law.
 
Supplemental Materials and Website
Supplemental information on this transaction may be found at www.tnibiotech.com/investor-relations. This press release has also been furnished to the SEC in a current report on Form 8-K.
TNI BioTech routinely posts important information online on its website,www.tnibiotech.com /investor-relations. TNI BioTech uses this website, press releases, SEC filings, and webcasts to disclose material, non-public information in accordance with Regulation FD. TNI BioTech encourages members of the investment community to monitor these distribution channels for material disclosures. Any information accessed through TNI BioTech's website is not incorporated by reference into, and is not a part of, this document.
 
Media Contact
Dennis S. Dobson 
Dobson Media Group 
203-258-0159 
dennisdobsonjr@dobsonmediagroup.com

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