0000000000-20-006073.txt : 20201013 0000000000-20-006073.hdr.sgml : 20201013 20200707172840 ACCESSION NUMBER: 0000000000-20-006073 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20200707 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: GENEREX BIOTECHNOLOGY CORP CENTRAL INDEX KEY: 0001059784 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 820490211 STATE OF INCORPORATION: DE FISCAL YEAR END: 0731 FILING VALUES: FORM TYPE: UPLOAD BUSINESS ADDRESS: STREET 1: 10102 USA TODAY WAY CITY: MIRAMAR STATE: FL ZIP: 33025 BUSINESS PHONE: 416-364-2551 MAIL ADDRESS: STREET 1: 10102 USA TODAY WAY CITY: MIRAMAR STATE: FL ZIP: 33025 PUBLIC REFERENCE ACCESSION NUMBER: 0001607062-20-000047 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4*)>+CS],*,2 P(&]B:@H\/"]4>7!E+UA/8FIE8W0O0V]L;W)3 M<&%C92]$979I8V5',Z%$;3 BU,"VEA6J % M6J %6J %6J %6J %6O ]*WOEK(,D*\X#9H:[]P]6<&19EAU+^GP>RR(B(B(B M(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B(B+_-A\?'^_O[V]O;Z^OKR\' MGI^?GP[$AY="%(AB43AV^=.M%A$1$1$1$9$?2,H4S\_/CX^/]_?WOP[<'=E- MR6+L]?OW[ZCAZ>GI]?5504-$1$1$1$1$+N;M[>WIZ>GAX6&_WS<"Q:]?O^[O M[^.KQW.(\K]__VZJBLJ1,EY>7M0Q1$1$1$1$1&3"Q\<'QA6_?__&K *98K_? 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end TEXT-EXTRACT 2 filename2.txt United States securities and exchange commission logo July 7, 2020 Joseph Moscato Chief Executive Officer Generex Biotechnology Corporation 10102 USA Today Way Miramar, FL 33025 Re: Generex Biotechnology Corporation Amendment No. 1 to Registration Statement on Form S-1 Filed June 15, 2020 File No. 333-236481 Dear Mr. Moscato: We have reviewed your amended registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Unless we note otherwise, our references to prior comments are to comments in our March 3, 2020 letter. Amendment No. 1 to Registration Statement on Form S-1 Recent Developments, page 4 1. We refer to prior comment 1 and reissue in part. Please revise to identify and discuss the assets held by your NGIO subsidiary. In this regard, we note that the January 31, 2020 balance sheet filed with NuGenerex's Form 10 registration statement indicates that the only assets consisted of $174 in cash. 2. We note your disclosure on page 96 indicating that pursuant to a May 2020 ruling Generex may not issue, transfer or otherwise dispose of any shares of stock without receiving court approval from the judge in the Utah Third District Court. Please revise to highlight this disclosure in your Summary. Joseph Moscato Generex Biotechnology Corporation July 7, 2020 Page 2 Corporate Development Concerning COVID-19, page 6 3. Please revise to clarify the basis for your statement that you have developed a proprietary, patented Ii-Key immune system activation technology that holds promise for the rapid development of a complete SARS-COV-2 Ii-Key peptide vaccine to address the current COVID-19 pandemic. Alternatively, please revise to remove this and other similar statements from the registration statement. As applicable, also revise this section to clarify, if true, that you have not conducted any clinical or pre-clinical testing to date. Steps taken..., page 49 4. Please revise the disclosure on page 52 to explain your basis for the statement that "funding for the development of a vaccine of SARS-CoV-2 virus is in advanced discussions and currently expected that the development costs will be borne by the U.S. and foreign government agencies." General 5. We note your response to our prior comment 2 and reissue in part. Please revise the prospectus to address corporate developments concerning the development of a rapid test for 2019-nCOV by NuGenerex Diagnostics or explain why this information is not material to investors. 6. As you know, the staff is reviewing your Annual Report on Form 10-K for the fiscal year ended July 31, 2019 and have issued comments in connection with that review. Please note that we will not be in a position to declare this registration statement effective until you have resolved all comments raised on the Form 10-K. Please contact Ada D. Sarmento at 202-551-3798 or Joe McCann at 202-551-6262 with any questions. Sincerely, FirstName LastNameJoseph Moscato Division of Corporation Finance Comapany NameGenerex Biotechnology Corporation Office of Life Sciences July 7, 2020 Page 2 cc: Marc J. Ross, Esq. FirstName LastName