GNBT Generex Biotechnology Corporation (CE)

Item 8.01 Other Events.

On April 28, 2021, Generex Biotechnology Corporation and its subsidiary Olaregen Therapeutix Inc., (collectively “Generex”) signed a Distribution Agreement with Nexgen Medical Sdn Bhd incorporated and registered in Malaysia (“Nexgen”) to be Generex’s exclusive distributor to import, market and sell Olaregen Therapeutix Inc’s Excellagen line of products in Malaysia. First purchase minimum is 500 units 0.8cc syringes of Excellagen, with an additional 500 units 0.8cc syringes of Excellagen to be purchased within a year. Nexgen expects their ministry of health approval, which has been submitted, by end of May 2021.

Forward-Looking Statements

Statements in this report may contain certain forward-looking statements. All statements included concerning activities, events or developments that the Generex expects, believes or anticipates will or may occur in the future are forward-looking statements. Actual results could differ materially from the results discussed in the forward-looking statements. Forward-looking statements are based on current expectations and projections about future events and involve known and unknown risks, uncertainties and other factors that may cause actual results and performance to be materially different from any future results or performance expressed or implied by forward-looking statements. Known risks and uncertainties also 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. Additional information on these and other risks, uncertainties and factors is included in the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8- K and other documents filed with the SEC.