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Generex Biotechnology Corp. (NASDAQ: GNBT)(D*)

* Financial status indicator is deficient: Issuer failed to meet NASDAQ continued listing requirements.

Generex Biotechnology Corp. (GNBT) is engaged in the research, development and commercialization of drug delivery systems and technologies. The Company focuses on its technology for the administration of formulations of large molecule drugs to the oral (buccal) cavity using a hand-held aerosol applicator. Its wholly owned subsidiaries include Generex Pharmaceuticals Inc., Antigen Express Inc., Generex (Bermuda) Inc., Generex Pharmaceuticals (USA) LLC and Generex Marketing & Distribution Inc. The Company is in development stage. In September 2009, the Company announced the incorporation of SIA Generex Biotechnology BALTIC as a wholly owned subsidiary. The Company’s products include Generex Oral-lyn, an insulin spray formulation used for the treatment of type-1 and type-2 diabetes; Glucose RapidSpray, which provides an alternative for people who require additional glucose in their diet, as well as delivers glucose formulation directly into the mouth; BaBOOM! Energy Spray, an instant energy spray designed to increase energy levels for sports, work, study, travel and overall fatigue; and Crave-NX, a fat-free glucose spray that is used as an aid for dieters. GNBT’s under development products include medicinal chewing gum for the treatment of type-2 diabetes mellitus and obesity; morphine and fentanyl products for breakthrough and postoperative pain; and AE37, an immunotherapeutic vaccine that is in phase II clinical trials for patients with HER-2/neu positive breast cancer. The Company markets its products through distributors and retail chains in Ecuador, Canada and the United States.

The Company was founded in 1983 and is based in Toronto, Canada.

Source: Reuters.com, SEC Filings.

Financial Summary

No financial reports available.

Source: Reuters.com, SEC Filings.

Analyst Consensus

No chart available.

Source: www.ft.com

No consensus analysis data available.

Source: http://www.reuters.com/finance/stocks/financialHighlights?symbol=GNBT.W

Investment Highlights

GNBT recently announced the publication of results from the first phase I study of its lead immunotherapeutic agent AE37 in patients with prostate cancer. At the end of 2009, the Company announced positive interim results from a phase II trial being conducted with AE37 in patients with breast cancer. The compound is being developed by its wholly owned subsidiary, Antigen Express Inc.

The report, entitled, “Results from a phase I clinical study of the novel Ii-Key/HER-2/neu(776-790) hybrid peptide vaccine in patients with prostate cancer,” is being published (online publication date = May 13, 2010) in the journal Clinical Cancer Research, a journal of the American Association for Cancer Research whose focus is to publish innovative clinical and translational cancer research studies that bridge the laboratory and the clinic. The study extends previous observations demonstrating safety and immunological activity of AE37 in cancer patients. Interestingly, a decrease in the circulating levels of a fragment of the HER-2/neu protein was also observed in immunized patients. These results warrant a phase II clinical study to establish the efficacy of AE37 in prostate cancer patients.

GNBT recently announced that it has achieved enrollment of more than 400 subjects in its pivotal global phase III study of its flagship product, Generex Oral-lyn(TM), a proprietary buccal insulin spray product designed to replace prandial injections of insulin.

GNBT will continue to monitor and execute the ongoing Generex Oral-lyn(TM) study according to protocol and national/international ICH-GCPs. The study’s endpoint is for Generex Oral-lyn(TM) to achieve non-inferiority to injectable meal-time (prandial) insulin. Formal verification of the non-inferiority hypothesis should be achieved by the statistical power set out in the protocol. Following the execution of the study’s first interim analysis in approximately two months, the enrollment of additional subjects in the study may possibly be terminated. This in turn would establish an approximate end-of-study-treatment-period in December 2010.

To date, no Generex Oral-lyn(TM) drug-related “Serious Adverse Events” (SAEs) have been reported, which also supports the current initiatives of the study.

The Company believes that Generex Oral-lyn(TM) offers a safe, simple, fast, effective and needle-free alternative to prandial insulin injections, which will improve patient compliance with therapeutic regimens, thereby delaying the progress of diabetes and the onset of its myriad complications.

Source: http://www.generex.com/

Technical Analysis

Source: http://stockcharts.com

GNBT is below its 50-day moving average. This bearish sign is even more significant because the moving average is also trending lower.

GNBT’s recent volatility has been greater than normal. This is evidenced by the increased distance between the upper and lower Bollinger Bands. These bands measure volatility using standard deviation and a large width is due to high volatility. Additionally, GNBT is trading near its lower Bollinger Band. This suggests that the stock price is low relative to its recent price action.

The MACD for GNBT currently indicates a strong bearish signal for two reasons. First, the MACD is below the signal line, a 9-day moving average. Second, the MACD is below the critical level of zero, which implies that the underlying moving averages are trending lower.

Comparative Analysis

Source: Thomson Financial

Insider Trading Activity

Source: Yahoo Finance

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