A unique opportunity for GNBT to expand the scope of its business
WORCESTER, Mass. and TORONTO, Oct. 6, 2015 /CNW/ — Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) today announced that it has entered into a non-binding Letter of Intent (LOI) with Alfa Rhythm Ltd. (Alfa) (www.alfarhythm.com), a private Israeli company that has developed a proprietary trans-cranial electro-biometric stimulator for the treatment of symptoms of attention deficit hyperactivity disorder (ADHD), depression, anxiety, and sleep disorders.
The product, which is the subject of a current United States patent application, is designed to emit frequency-specific low-voltage electric pulses for cerebral stimulation with the goal of modulating brainwaves to enhance attentiveness and concentration.
The self-operated, compact apparatus is non-invasive, easy to use, and safe for all ages. The user sets the desired frequency and wears the lightweight apparatus on the forehead for 10 to 30 minutes. The apparatus is charged via mini USB.
As well as promoting general mental function and well being by enhancing attention, concentration, creativity, and memory, the goal of the product is to provide symptomatic relief for ADHD, the various forms of depression, anxiety (including generalized anxiety disorder (GAD)), and sleep disorders such as insomnia, sleep apnea, narcolepsy, and restless leg syndrome.
Given that the problems the Alfa Rhythm product is designed to address are endemic in modern first-world societies, and the dearth of extant satisfactory treatments and therapies, the potential market for the product is enormous. Alfa intends to initially market the stimulator as a “wellness” product in North America and Europe whilst undertaking the clinical work that is a condition precedent to regulatory sanction of the product for the treatment of disorders such as epilepsy and Parkinson’s disease.
The LOI contemplates that Generex will acquire a 51% equity interest in Alfa in exchange for a purchase price of US$5,000,000 to be paid in accordance with an Alfa business plan identifying a timeline, milestones, and a budget. Generex will also receive a royalty equal to 8% of gross sales of the products.
The discussions between Generex and Alfa are at an early stage, and the LOI does not assure that the arrangements contemplated thereby will be achieved. Valuation and other due diligence exercises must be completed. Even if Generex and Alfa enter into formal arrangements, any benefit from those arrangements will depend upon the ability of Alfa to execute its business plan to achieve successful commercialization and on the ability of Generex to raise the requisite funding for the acquisition of the equity.
About Generex Biotechnology Corporation
Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company’s proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company’s proprietary RapidMist™ device. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation technologies in immunotherapy. One focuses on modification of peptides with Ii-Key to increase potency, while a second relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as “expects,” “plan,” “believes,” “will,” “achieve,” “anticipate,” “would,” “should,” “subject to” or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any “phase” of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.