Acusphere Announces Closing Of $10 Million Financing To Support Continued Development Of Imagify

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).