UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): September 21, 2010
ACCENTIA BIOPHARMACEUTICALS, INC.
(Exact name of Registrant as Specified in its Charter)
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Florida | | 000-51383 | | 04-3639490 |
(State or other jurisdiction of incorporation or organization) | | (Commission File Number) | | (I.R.S. Employer Identification No.) |
324 South Hyde Park Ave., Suite 350
Tampa, Florida 33606
(Address of Principal Executive Offices; Zip Code)
Registrant’s telephone number, including area code: (813) 864-2554
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) |
¨ | 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)) |
ACCENTIA BIOPHARMACEUTICALS, INC.
FORM 8-K
Item 7.01. | Regulation FD Disclosure. |
The following information is being furnished under Item 7.01 of Form 8-K:
| a. | Press release dated September 23, 2010, by the Company’s majority owned subsidiary, Biovest International, Inc., titled “Biovest to Exhibit at Lymphoma Research Foundation’s Annual Educational Forum; Personalized Cancer Vaccine Study Expert Scheduled to Present”. A copy of this press release is attached as Exhibit 99-1 to this Form 8-K; and |
| b. | On September 21, 2010, the Debtors filed their unaudited combined monthly operating report for the period August 1, 2010 through August 31, 2010 (the “Monthly Operating Report”) with the United States Bankruptcy Court for the Middle District of Florida, Tampa Division (the “Bankruptcy Court”). Exhibit 99-2 to this Current Report on Form 8-K contains the unaudited Monthly Operating Report as filed with the Bankruptcy Court. |
The Monthly Operating Report is limited in scope, covers a limited time period and has been prepared solely for the purpose of complying with reporting requirements of the Bankruptcy Court and the Bankruptcy Code, 11 U.S.C. §§ 101-1532 (the “Bankruptcy Code”). The financial information contained in the Monthly Operating Report is preliminary and unaudited and does not purport to show the financial statements of any of the Debtors in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and, therefore, may exclude items required by GAAP, such as certain reclassifications, eliminations, accruals and disclosure items. The Company cautions readers not to place undue reliance on the Monthly Operating Report. The Monthly Operating Report may be subject to revision. The Monthly Operating Report is in a format required by the Bankruptcy Court and the Bankruptcy Code and should not be used for investment purposes. The information in the Monthly Operating Report should not be viewed as indicative of future results.
This Current Report on Form 8-K sets forth statements that are not strictly historical in nature constitute “forward-looking statements”. Such statements include, but are not limited to, statements about Revimmune™, BiovaxID®, and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials, the intent to treat analysis, accelerated approval and all aspects of the regulatory process. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, expectations and intentions, and other statements identified by words such as “may,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of the Company to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements in this Form 8-K are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update this Current Report on Form 8-K to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.
Limitation on Incorporation by Reference
The Monthly Operating Report is being furnished for informational purposes only and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended. Registration statements or other documents filed with the U.S. Securities and Exchange Commission shall not incorporate the Monthly Operating Report or any other information set forth in this Current Report on Form 8-K by reference, except as otherwise expressly stated in such filing. This Current Report on Form 8-K will not be deemed an admission as to the materiality of any information in the report that is required to be disclosed solely by Regulation FD.
Item 9.01. | Financial Statements and Exhibits. |
See the Exhibit Index set forth below for a list of exhibits included with this Form 8-K.
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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 thereunder duly authorized.
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ACCENTIA BIOPHARMACEUTICALS, INC. |
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By: | | /s/ Samuel S. Duffey |
| | Samuel S. Duffey |
| | President & General Counsel |
Date: September 24, 2010
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EXHIBIT INDEX
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Exhibit Number | | Description |
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99.1 | | Press Release dated September 23, 2010 titled, “Biovest to Exhibit at Lymphoma Research Foundation’s Annual Educational Forum; Personalized Cancer Vaccine Study Expert Scheduled to Present”. |
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99.2 | | Monthly Operating Report of Accentia Biopharmaceuticals, Inc. for the period August 1, 2010 through August 31, 2010 filed in the United States Bankruptcy Court Middle District of Florida Case No. 8:08-bk-17795-KRM Document No. 1202. |
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