-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Vvwr3FVbQsG1yRWlqC9BHijC7fOvnZvgJR5UWgw8hEjdXwyl62NpBvqAs8+qjCTp dkqHYsjmKbzPPWTTPNbucw== 0001144204-08-041917.txt : 20080725 0001144204-08-041917.hdr.sgml : 20080725 20080725160541 ACCESSION NUMBER: 0001144204-08-041917 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080723 ITEM INFORMATION: Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080725 DATE AS OF CHANGE: 20080725 FILER: 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: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-25169 FILM NUMBER: 08970946 BUSINESS ADDRESS: STREET 1: 33 HARBOUR SQ STREET 2: STE 202 CITY: TORONTO ONTARIO CANADA STATE: A1 ZIP: M5J 2G2 BUSINESS PHONE: 4163642551 MAIL ADDRESS: STREET 1: 33 HARBOUR SQ STREET 2: STE 202 CITY: TORONTO ONTARIO CA STATE: A1 ZIP: M5J 2G2 8-K 1 v120812_8k.htm

 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549


FORM 8-K

CURRENT REPORT

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


Date of Report (Date of earliest event reported): July 23, 2008


GENEREX BIOTECHNOLOGY CORPORATION
(Exact Name of Registrant as Specified in Its Charter)
   
 

Delaware
000-25169
98-0178636
(State or Other
(Commission
(IRS Employer
Jurisdiction of
File Number)
Identification
Incorporation)
 
Number)
 
 
 
 
 
 
33 Harbour Square, Suite 202, Toronto, Ontario Canada
M5J 2G2
(Address of Principal Executive Offices)
(Zip Code)
 
 
 
 
 
 
Registrant’s telephone number, including area code: (416) 364-2551
 
 
 
 
 
 
N/A
(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 (see General Instruction A.2. below):

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

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

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

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

 
Item 3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
 
On July 23, 2008, Generex Biotechnology Corporation received notice from The Nasdaq Stock Market informing Generex that it does not comply with Marketplace Rule 4310(c)(4), which requires Generex to have a minimum bid price per share of at least $1.00 for thirty (30) consecutive business days.
 
In accordance with Marketplace Rule 4310(c)(8)(D), Generex has 180 calendar days, or until January 20, 2009, to regain compliance with the Rule. If, at anytime prior to January 20, 2009, the bid price of Generex’s common stock closes at $1.00 per share or more for a minimum period of ten (10) consecutive business days, Generex will regain compliance with the Rule.
 
As described in its recent filings with the Securities and Exchange Commission, Generex has on-going enrollment of patients in late-stage clinical trials of its flagship product, Generex Oral-lyn, in the United States, Canada, Europe and certain countries in Eastern Europe. As these trials progress, Generex expects to use the data collected from these trials in the regulatory filings for product approvals in the United States, Canada and Europe. Generex believes that as these trials progress, investor confidence in Generex will increase, which would have a positive effect on its stock price, such that its common stock would meet the minimum bid price requirement under Marketplace Rule 4310(c)(4).
 
In the event compliance with Marketplace Rule 4310(c)(4) cannot be demonstrated by January 20, 2009, the Staff will determine whether Generex meets The Nasdaq Capital Market initial listing criteria as set forth in Marketplace Rule 4310(c), except for the bid price requirement. If Generex meets the initial listing criteria, the Staff will grant an additional 180 calendar day period for Generex to regain compliance. If Generex cannot regain compliance and is not eligible for an additional compliance period, the Staff will notify Generex that its securities will be delisted, at which time Generex may appeal the Staff’s determination to a Listing Qualifications Panel.
 
Safe Harbor Statement
 
This Current Report on Form 8-K, the attached release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain “forward-looking statements’’ within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as “expects,’’ “plans,’’ “intends,’’ “believes,’’ “will,’’ “estimates,’’ “forecasts,’’ “projects,’’ or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties 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 cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any “phase’’ of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
 
Item 9.01
Financial Statements and Exhibits.
 
 
(d)
Exhibits
 

 
99.1
Press Release of Generex Biotechnology Corporation., dated July 25, 2008, reporting Generex’s receipt of Nasdaq notice dated July 23, 2008. Filed herewith.
 


 
SIGNATURE

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.
 
     
 
GENEREX BIOTECHNOLOGY CORPORATION
 
 
 
 

 
 
Date: July 25, 2008
By:   /s/ Rose C. Perri
 
 
Chief Operating Officer and
Chief Financial Officer
(principal financial officer)
 
 
EX-99.1 2 v120812_ex99-1.htm
 
 
 
 
Exhibit 99.1

GENEREX BIOTECHNOLOGY GRANTED ADDITIONAL
TIME TO COMPLY WITH NASDAQ LISTING
REQUIREMENT

WORCESTER, Mass., July 25, 2008 (PRIME NEWSWIRE) -- Generex Biotechnology Corporation (NasdaqCM:GNBT, www.generex.com), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it has been notified by The Nasdaq Stock Market that the bid price of its common stock had closed below $1.00 for 30 consecutive business days. In accordance with NASDAQ Marketplace Rule 4450(e)(2), the Company was granted 180 calendar days, or until January 20, 2009, to regain compliance with the Minimum Bid Price Rule. If the bid price for the Company’s common stock closes at $1.00 per share or more for 10 consecutive business days within the period provided, the Company will have achieved compliance. The Company intends to monitor the bid price for its common stock and consider options available to the Company to achieve compliance with NASDAQ listing standards.

About Generex Biotechnology Corporation
Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies.  Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs).  The Company’s proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company’s proprietary RapidMist™ device.  The Company’s flagship product, oral insulin (Generex Oral-lyn™), which is available for sale in Ecuador for the treatment of patients with Type-1 and Type-2 diabetes and which was approved for sale in India in October 2007, is in Phase III clinical trials at several sites around the world.  For more information, visit the Generex website at www.generex.com
 
Safe Harbor Statement
 
This release and oral statements made from time to time by Generex representatives concerning the same subject matter may contain “forward-looking statements’’ within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as “expects,’’ “plans,’’ “intends,’’ “believes,’’ “will,’’ “estimates,’’ “forecasts,’’ “projects,’’ or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties 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 cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any “phase’’ of clinical trials. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
 
 
Contact:
         American Capital Ventures, Inc.
         For Generex:
         Howard Gostfrand
         305-918-7000
        
         CEOcast, Inc.
         Andrew Hellman
         212-732-4300
 
 
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