Biovest Files Recapitalization Plan to Strengthen Balance Sheet & Advance Commercialization Strategy for BiovaxID™ Cancer V...
March 07 2013 - 04:45PM
Business Wire
Biovest International, Inc. (OTCQB:BVTI) today reported that the
Company has filed a petition for protection under Chapter 11 of the
U.S. Bankruptcy Code and a Plan of Reorganization (the “Plan”)
seeking to implement a restructuring of its balance sheet that
would eliminate approximately $44 million in senior secured debt
held by Laurus/Valens Funds and Corp Real, LLC (the “senior secured
debt”) while also providing up to approximately $5.6 million in new
operating funding. Subject to the Plan becoming effective, Biovest
expects the Plan would significantly strengthen its balance sheet
and support ongoing strategies to commercialize its BiovaxID™
personalized cancer vaccine, including facilitating ongoing
partnering/licensing initiatives, as well as enhancing the
opportunity to secure new contracts establishing its hollow fiber
bioreactors as a novel cell culture platform for viral vaccine
production.
During this reorganization process, Biovest plans to continue
its operations without interruption, including advancing its
regulatory strategy seeking approvals for BiovaxID in the European
Union and Canada for the treatment of follicular non-Hodgkin’s
lymphoma. The Company plans to file these formal marketing
applications following completion of its reorganization with
regulatory decisions anticipated in 2014. If approved, BiovaxID
would be the first cancer vaccine available for lymphoma patients.
Biovest will also continue to service its cell culture and
instruments clients from its Minneapolis facility without
interruption.
Based on filings made to the Bankruptcy Court, Biovest will seek
access for up to approximately $5.6 million in new funding being
provided by Biovest’s senior secured lenders. The Plan also
proposes that approximately $44 million of Biovest’s senior secured
debt, which includes the new funding, would be converted into
common stock on the effective date of the Plan, thereby eliminating
the Company’s senior secured debt upon exit from bankruptcy.
Biovest’s largest senior secured lenders have indicated support
for the Plan, and the Company expects to complete the restructuring
and emerge from Chapter 11 by mid-2013. The reorganization filing
was made in the U.S. Bankruptcy Court for the Middle District of
Florida, Tampa Division, and Biovest’s bankruptcy counsel is the
law firm of Stichter, Riedel, Blain & Prosser P.A.
All terms proposed in the Plan, as well as in subsequent related
filings, will be subject to acceptance by the Bankruptcy Court and
will ultimately require final approval by the Bankruptcy Court in
order to become effective.
About Biovest International,
Inc.
Biovest International, Inc. develops active immunotherapies
(cancer vaccines) which treat and diminish the aggressiveness of
B-cell non-Hodgkin’s lymphoma, a cancer of the immune system. The
Company’s lead personalized cancer vaccine product candidate,
BiovaxID™, has been evaluated in three clinical trials conducted in
collaboration with the U.S. National Cancer Institute (NCI)
demonstrating that BiovaxID increases the duration of cancer
remission following chemotherapy and induces immune responses which
correlate highly with long-term survival. Biovest is currently in
the process of pursuing European and Canadian marketing approvals
for BiovaxID.
Headquartered in Tampa, Florida with its bio-manufacturing
facility based in Minneapolis, Minnesota, Biovest is
publicly-traded on the OTCQB™ Market with the stock-ticker symbol
“BVTI”.
For further information, please visit:
http://www.Biovest.com
Forward-Looking
Statements:
Statements in this press release that are not strictly
historical in nature constitute "forward-looking statements.”
Such statements include, but are not limited to, statements
about Biovest and its petition in Chapter 11 reorganization and
proposed Plan of Reorganization, product candidate, BiovaxID™ and
any other statements relating to products, product candidates,
product development programs, the FDA, the EMA, Health Canada or
clinical study process including the commencement, process, or
completion of clinical trials or 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
“proposed”, “proposes”, “seeking”, "may," "could," "would,"
"should," "believes," "expects," "anticipates," "estimates,"
"intends," "plans," or similar expressions. In particular (and
without limitation), statements regarding the timing of anticipated
filing of a Marketing Authorization Application for BiovaxID with
the EMA or a New Drug Submission for BiovaxID with Health Canada,
pre-filing meetings with the FDA or other jurisdictions and/or
commercial plans reflect current expectations but are subject to
inherent risks of delay in compilation and finalization of all
components of the licensing application. Such forward-looking
statements involve known and unknown risks, uncertainties, and
other factors that may cause the actual results of Biovest 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 are
qualified in their entirety by this cautionary statement, and
Biovest undertakes no obligation to revise or update this news
release 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.