Transaction Details
Press Release
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Acusphere Announces Closing of $10 Million Financing to Support Continued Development of Imagify
Funds to be used towards submission of a Marketing Authorisation Application in Europe and a Special Protocol Assessment in the United States
CAMBRIDGE, Mass., Jun 30, 2010 (BUSINESS WIRE) -- 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(TM) (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(TM) (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 forwardlooking
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.
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