1.We have a history of losses and will incur additional losses.
2.To date, we have not been profitable and our accumulated net loss available to shareholders was $294,041,489 at July 31, 2009
3.We will need additional capital.
To progress in product development or marketing, we will need additional capital which may not be available to us. This may delay our progress in product development or market.
4.Our research and development and marketing efforts may be highly dependent on corporate collaborators and other third parties who may not devote sufficient time, resources and attention to our programs, which may limit our efforts to successfully develop and market potential products.
5.our technologies and products are at an early stage of development and we cannot expect significant revenues in respect thereof in the foreseeable future.
6.Until we receive regulatory approval to sell our pharmaceutical products in additional countries, our ability to generate revenues from operations may be limited and those revenues may be insufficient to sustain operations. Many factors impact our ability to obtain approvals for commercially viable products.
7.Delays in obtaining United States or other foreign approvals for our pharmaceutical products could result in substantial additional costs to us, and, therefore, could adversely affect our ability to compete with other companies. If regulatory approval is ultimately granted in any countries other than Ecuador, Lebanon, Algeria and India, the approval may place limitations on the intended use of the product we wish to commercialize, and may restrict the way in which we are permitted to market the product.
8.Due to legal and factual uncertainties regarding the scope and protection afforded by patents and other proprietary rights, we may not have meaningful protection from competition.
9.Because a substantial number of patents have been issued in the field of alternative drug delivery and because patent positions can be highly uncertain and frequently involve complex legal and factual questions, the breadth of claims obtained in any application or the enforceability of our patents cannot be predicted. Consequently, we do not know whether any of our pending or future patent applications will result in the issuance of patents or, to the extent patents have been issued or will be issued, whether these patents will be subject to further proceedings limiting their scope, will provide significant proprietary protection or competitive advantage, or will be circumvented or invalidated.
10.We may not become, or stay, profitable even if our pharmaceutical products are approved for sale.
11.We will not receive significant revenues from Generex Oral-lyn™ or any of our other pharmaceuticals products that may receive regulatory approval until we can successfully manufacture, market and distribute them in the relevant markets.
12.We may not be able to compete with treatments now being marketed and developed, or which may be developed and marketed in the future by other companies.
13.We have to depend upon others for marketing and distribution of our products, and we may be forced to enter into contracts limiting the benefits we may receive and the control we have over our products.
14.If government programs and insurance companies do not agree to pay for or reimburse patients for our pharmaceutical products, our success will be impacted.