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Washington, D.C. 20549



Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934


Date of Report (Date of earliest event reported): January 31, 2013




(Exact name of registrant as specified in its charter)


Delaware   000-29169   98-0178636

(State or other jurisdiction of


  (Commission File Number)   (I.R.S Employer Identification No.)


555 Richmond Street West, Suite 604 Toronto, Ontario, Canada   M5J 2G2
(Address of principal executive offices)   (Zip Code)


Registrant’s telephone number, including area code: (416) 364-2551


33 Harbour Square, Suite 202, Toronto, Ontario Canada

(Former name or former address, if changed since last report.)


Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


x Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))



Item 7.01 Regulation FD Disclosure.

Item 8.01 Other Events.


On January 31, 2013 at 10:00 a.m. Eastern time, Generex Biotechnology Corporation (“Generex”) hosted a conference call to discuss recent activity and management's go-forward plans, including the clinical and regulatory status of the AE37 breast cancer vaccine and business development initiatives; the clinical and regulatory status of the Generex Oral-lyn™ buccal insulin spray product; the status of the proposed spinout of Antigen Express; Generex finances; and, the annual and special meeting of the Generex's stockholders (scheduled for March 28, 2013). The transcript of the conference call is furnished as Exhibit 99.1 to this report.


The foregoing information in Item 7.01 of this Current Report on Form 8-K, together with the transcript of the conference call attached hereto as Exhibit 99.1, is being furnished pursuant to this Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to Item 7.01 of this Current Report on Form 8-K.


By filing this Current Report on Form 8-K and furnishing this information, Generex makes no admission as to the materiality of Item 7.01 in this report or the transcript of the conference call attached hereto as Exhibit 99.1. The information contained in the transcript of the conference call is summary information that is intended to be considered in the context of Generex’s filings with the SEC and other public announcements that Generex makes, by press release or otherwise, from time to time. Generex undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.


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.  Such risks and uncertainties include the risks that (1) Generex will not obtain the stockholder approval of the increase in authorized shares or reverse stock split; (2) the reverse stock split, if implemented, will fail to have the desired effect of sufficiently raising the common stock price; and (3) the anticipated benefits of the proposed spin off of Antigen and right offering to stockholders will not be realized.  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.


Item 9.01 Financial Statements and Exhibits.


  (d) Exhibits.
  99.1 Script of Generex Biotechnology Corporation’s conference call on January 31, 2013 and transcript of related question and answer session.





Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


Date: January 31, 2013   /s/ Mark A. Fletcher
    Mark A. Fletcher
    President and Chief Executive Officer







99.1   Script of Generex Biotechnology Corporation’s conference call on January 31, 2013 and transcript of related question and answer session.