Acusphere Inc (ACUS) SEC Filing 10-Q Quarterly report for the period ending Tuesday, September 30, 2008

Acusphere Inc

CIK: 1115143 Ticker: ACUS

Exhibit 99.1





Acusphere, Inc. Reports Q3 2008

Financial Results and Business Highlights


WATERTOWN, MA., November 10, 2008 — Acusphere, Inc. (NASDAQ: ACUS) today reported financial results for the third quarter ended September 30, 2008 and commented on its financial results and business highlights.


Recent Developments


Following the close of the third quarter, Acusphere announced a definitive agreement with Cephalon, Inc. to provide Acusphere with $20.0 million in upfront financing through the issuance of a $15.0 million senior secured convertible note and a $5.0 million upfront fee for an exclusive worldwide license to AI-525, a preclinical-stage injectable formulation of celecoxib using Acusphere’s proprietary Hydrophobic Drug Delivery System (HDDS™) technology. The transaction closed on November 3, 2008.


The Company also announced the transfer of the listing of its common stock to the Nasdaq Capital Market from the Nasdaq Global Market, effective October 29, 2008, and was granted additional time by NASDAQ to regain compliance with certain listing standards.


Business Priorities


Acusphere’s key priority is moving ahead with all aspects of the regulatory review of its lead product candidate, ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension, a cardiovascular drug for the detection of coronary artery disease, including preparations for the U.S. Food & Drug Administration (FDA) Advisory Committee meeting scheduled for December 10, 2008.


Acusphere has submitted to FDA a briefing document for the Advisory Committee and the FDA is in the process of preparing its own briefing document, both of which will become available to the public shortly before the Advisory Committee meeting. Acusphere’s briefing document summarizes product efficacy, diagnostic utility and product safety in the intended patient population as well as strategies to minimize concerns about potential off-label usage and safety issues that may arise when more patients are exposed to Imagify upon commercialization. In addition, preparations continue for the FDA pre-approval site inspection, which the Company believes will occur in late 2008 or early 2009.  The Company also continues to support the Marketing Authorization Application


The following information was filed by Acusphere Inc (ACUS) on Monday, November 10, 2008 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Definitive Proxy Statement (Form DEF 14A)
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Acusphere Inc's Definitive Proxy Statement (Form DEF 14A) filed after their 2008 10-K Annual Report includes:

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  • Board Members
  • Executive Team
  • Salaries, Bonuses, Perks
  • Peers / Competitors


SEC Filing Tools
Ticker: ACUS
CIK: 1115143
Form Type: 10-Q Quarterly Report
Accession Number: 0001104659-08-069664
Submitted to the SEC: Mon Nov 10 2008 3:22:55 PM EST
Accepted by the SEC: Mon Nov 10 2008
Period: Tuesday, September 30, 2008
Industry: Pharmaceutical Preparations

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