Acusphere, Inc. (ACUS.PK) today announced the closing of a definitive
agreement with Burrill & Company’s venture capital group to provide up
to $10 million in debt financing through the sale of a senior secured
note and warrant. Seven Hills Partners, LLC provided financial advisory
and investment banking services for this transaction.
The initial tranche will be $5 million and the resulting senior secured
note will have a five year term and an interest rate of 10%, compounded
annually and accrued on the principal amount of the note payable in cash
on the maturity date. Accompanying the note will be a warrant to
purchase 83,333,333 common shares at an exercise price of $0.12 per
share. The warrant will be exercisable immediately and have a term of 5
years.
Acusphere also has the option to draw on two additional $2.5 million
tranches upon filing a Marketing Authorisation Application (MAA) to the
European Medicines Agency (EMA) for Imagify™ (Perflubutane Polymer
Microspheres) for Injectable Suspension and upon reaching agreement with
the United States Food and Drug Administration (FDA) under the Special
Protocol Assessment (SPA) process on the design of an FDA-required Phase
3 study demonstrating that stress ultrasound with Imagify has benefits
relative to stress ultrasound without Imagify. These tranches will be on
similar terms as the initial tranche with the exception of the warrant
coverage, which, for each tranche, will be a warrant to purchase
27,777,778 common shares at an exercise price of $0.12 per share.
Special Protocol Assessment
The SPA process creates a written agreement between the FDA and a
sponsor concerning the clinical trial design, clinical endpoints and
other clinical trial issues that can be used to support regulatory
approval of a drug candidate. The process is intended to provide
assurance that if the agreed upon clinical trial protocol is followed,
the clinical trial endpoints are achieved and there is a favorable risk
benefit profile, the data may serve as the primary basis of an efficacy
claim in support of a New Drug Application (NDA).
About Acusphere, Inc.
Acusphere (ACUS.PK) is a specialty pharmaceutical company that develops
new drugs and improved formulations of existing drugs using its
proprietary microsphere technology. We are focused on developing
proprietary drugs that can offer significant benefits such as improved
safety and efficacy, increased patient compliance, greater ease of use,
expanded indications or reduced cost. Our lead product candidate,
Imagify™ (Perflubutane Polymer Microspheres) for Injectable Suspension,
is a cardiovascular drug for the detection of coronary artery disease,
the leading cause of death in the United States, for which a New Drug
Application (NDA) was submitted to the U.S. Food & Drug Administration
(FDA) in April 2008 and filed in June 2008. Imagify and the Company's
other product candidates were created using proprietary technology that
enables Acusphere to control the porosity and size of nanoparticles and
microspheres in a versatile manner that allows them to be customized to
address the delivery needs of a variety of drugs. For more information
about Acusphere visit the Company's web site (www.acusphere.com).
About Burrill & Company
Founded in 1994, Burrill & Company is a San Francisco-based global
leader in life sciences with activities in venture capital, private
equity, merchant banking and media. The Burrill family of venture
capital funds has over $950 million under management and its merchant
banking business is one of the industry leaders in life sciences
transactions. Visit http://www.burrillandco.com
for more information.
Forward-looking Statements
The above press release contains forward-looking statements,
including statements regarding, the NDA submission for Imagify and
likelihood of regulatory approval and the commercial opportunity for
Imagify. There can be no assurance that Imagify will be approved for the
indication the Company is seeking, or at all. The Company's actual
results may differ materially from those anticipated in these
forward-looking statements based upon a number of factors, including
anticipated operating losses and existing capital obligations,
uncertainties associated with research, development, testing and related
regulatory approvals, including uncertainties regarding regulatory
evaluation of the Company's statistical analysis plan and clinical trial
results and uncertainties regarding the potential effects of not
achieving clinical endpoints, limited time to date for the Company to
review the details of the clinical trial results, capital needs and
uncertainty of additional financing, uncertainties regarding the cost,
timing and ultimate success of the qualification of the Company's
commercial manufacturing facility in accordance with applicable
regulatory requirements, complex manufacturing, high quality
requirements, lack of commercial manufacturing experience, dependence on
third-party manufacturers, suppliers and collaborators, uncertainties
associated with intellectual property, competition, loss of key
personnel, uncertainties associated with market acceptance and adequacy
of reimbursement, technological change and government regulation. The
Company notes that effective as of March 3, 2009, pursuant to a Form 15
filing made with the SEC, it is not currently required to file periodic
reports with the SEC, including annual reports on Form 10-K, quarterly
reports on Form 10-Q and current reports on Form 8-K. Readers are
cautioned not to place undue reliance on any forward-looking statements,
which speak only as of the date of this press release. The Company
undertakes no obligation to publicly release the results of any
revisions to these forward-looking statements that may be made to
reflect events or circumstances that occur after the date of this press
release or to reflect the occurrence of unanticipated events.
