(PublicWire.com Press Release) –BETHESDA, Md., May 16, 2013 /PRNewswire/ — TNI BioTech, Inc., (OTC PINK: TNIB), a biotech company combating fatal diseases through the activation and mobilization of the body’s immune system using its patented immunotherapy, issued a letter to its shareholders from CEO Noreen Griffin and the company’s board of directors. The letter follows:
The board of directors of TNI BioTech, Inc. is very pleased to provide an update on the progress made over the last year. This update gives the company opportunity to provide detailed reviews of several key achievements, as well as share a brief outline of the steps being taken to maximize shareholder value over the coming months.
The company, as of May 15, 2013, filed its first Q1 2013 financials with the Securities and Exchange Commission and OTC markets. This milestone, in conjunction with the filing of a Form 10, allows the company to become fully reporting. While waiting for approval of its Form 10, the company will file the required documents to trade on the QX OTC market, providing improved transparency to the investment community.
The company recently announced the hiring of Dr. Joseph Fortunak and Mr. Terry Lierman, the first of some upcoming changes that will enhance the executive team and build a world class biotech firm. In addition, the company has begun the hiring process of both a new Chief Operating Officer and President with extensive experience in biotech management. As the company prepares to up list to a national exchange, it will add to its corporate governance by forming audit and compensation committees.
As part of the agreement between TNI BioTech, Inc. and the University of Pennsylvania, Dr. Jill Smith , Dr. Ian S. Zagon , Dr. Patricia J. McLaughlin , and Moshe Rogosnitzky , the company gained the right to apply to the Food and Drug Administration (FDA) for the transfer of the Orphan Drug Designation and the Investigative New Drugs (IND) status. The company is pleased to announce that on April 3, 2013, it received acknowledgement from the Department of Health and Human Services confirming the FDA’s receipt of the change in sponsorship of the IND application for Naltrexone HCL along with the orphan drug designation for both [met5]-enkephalin and low dose naltrexone (LDN) in the treatment of pediatric patients with Crohn’s disease.
In May 2013, TNI BioTech, Inc. received confirmation of a Type C meeting with the FDA to discuss the Phase III clinical development program for a proposed 505(b)(2) application for low dose naltrexone (LDN) in the treatment of adults and pediatric patients with Crohn’s disease. Additionally, the agreement with their partners was expanded to include clinical trials on pancreatic and liver cancer, allowing the company to fast track the development plans for pancreatic and liver cancers. The company is also moving forward in developing its other therapies and hopes to set additional FDA meetings to discuss the clinical trials for pancreatic cancer and other autoimmune diseases.
In March 2013, TNI BioTech, Inc. made a strategic decision to outsource its manufacturing. This decision was made when the joint venture partner was unable to provide a facility that met international standards for manufacturing resulting in the cancelling of the contract. The company concurrently entered into discussions with an existing facility in Managua, Nicaragua that has excess capacity. TNI BioTech, Inc. believes that between the facility in Nicaragua and the Qianjiang Pharmaceutical cGMP facility located in China, it should be able to begin delivering LDN by July, 2013.
In February, 2013, TNI BioTech, Inc. executed a Commissioned Processing contract, an Addendum to Venture Cooperation, and a Strategic Framework agreement with Hubei Qianjiang Pharmaceutical Co., LTD (HBQ). Under the Commissioned Processing contract, HBQ will manufacture LDN for the company. The Addendum to Venture Cooperation expands the scope of the originally executed agreement in October to include clinical trials on pancreatic and liver cancer. Under the Strategic Framework agreement, the parties aim to co-invest to develop and market products focusing on cancer and HIV/AIDS; and to also develop co-ventured distribution of the developed products in China, Central America, South America, Africa, and the United States.
In the African countries where TNI BioTech, Inc. currently has contracts, international laws require the exporting company provide a certificate of free sale. It took longer than anticipated to obtain the certificate, but the company believes all the required international documents will be ready to begin shipping in July of 2013.
We would like to offer a heartfelt thank you to each and every shareholder: past, current, and future for your unwavering support of our company and for also taking the time to read this important shareholder letter. We are extremely excited to continue to move forward with our development plan and to do everything in our power to add shareholder value.
Again thank you very much for your support of TNI BioTech, Inc.
We truly appreciate our shareholders.
Noreen Griffin , Chief Executive Officer on behalf of TNI BioTech, Inc.
About TNI Biotech, Inc.
TNI BioTech, Inc. is a biotech company with the goal of benefitting patients with chronic and often life-threatening diseases through the activation and rebalancing of the body’s immune system, using our patented immunotherapy.
Our products, technologies and patents are designed to harness the power of the immune system to improve the treatment of cancer, chronic infections such as HIV/AIDS, and autoimmune diseases and, such as Crohn’s disease, other types of inflammatory bowel disease, and multiple sclerosis.
Our most advanced clinical programs involve immunotherapy with methionine-enkephalin (MENK) or low dose naltrexone, which both work by triggering opioid receptors on immune cells, leading to an activation and expansion of various cells of the immune system.
Our proprietary technology, therapies and patents, will be used to treat a wide range of cancers. Our most advanced clinical programs involve immunotherapy that works by augmenting the number and functions of both T cells and natural killer (NK) cells in patients with deficient immune responses associated with advanced cancer or HIV/AIDS, and by rebalancing the immune responses in patients with autoimmune diseases, including Crohn’s disease and multiple sclerosis.
SPECIAL 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 “believes,” “anticipates,” “intends,” or “expects,” 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 the Company 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. The Company cautions that these and similar statements included in this report 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. The Company undertakes no obligation to publicly release any revisions to such forward-looking statements to reflect events or circumstances after the date hereof.