Key Developments For AspenBio Pharma, Inc.
AspenBio Pharma, Inc. (APPY.O) (Consolidated Issue listed on NASDAQ Capital Market)
AspenBio Pharma, Inc. Announces Closing of Public Offering of 5,155,000 Common Shares
AspenBio Pharma, Inc. announced the closing of its previously announced public offering of 5,155,000 shares of its common stock at $1.70 per share. The aggregate number of shares of common stock sold reflects the exercise in full by the underwriter of its over-allotment option to purchase 672,391 additional shares of common stock. The approximately $8.3 million of net proceeds, after deducting the underwriting discounts and commissions and estimated offering expenses, will be used for product development, FDA 510(k) submission related activities, general corporate purposes, and working capital. ThinkEquity LLC acted as the sole underwriter for the offering.
AspenBio Pharma, Inc. Announces Public Offering of 4,482,609 Common Shares
AspenBio Pharma, Inc. announced that it has priced a public offering of 4,482,609 shares of its common stock at $1.70 per share. The approximately $7.2 million of net proceeds, after deducting the underwriting discounts and commissions and estimated offering expenses, will be used for product development, FDA 510(k) submission related activities, general corporate purposes, and working capital. The offering is expected to close on or about October 13, 2009. The sole underwriter for the offering is ThinkEquity LLC. The underwriter has been granted a 30 day option to purchase up to an additional 672,391 shares to cover over allotments, if any.
AspenBio Pharma, Inc. 510(k) Filing For AppyScore Advances In FDA Review With Request For Additional Information
AspenBio Pharma, Inc. announced that it has received a request from the U.S. Food and Drug Administration (FDA) for additional information related to AspenBio's Premarket Notification 510(k) application for its AppyScore test filed in late June 2009. The AppyScore test is the first blood-based test designed to aid in the diagnosis of human appendicitis. The Company is continuing to evaluate the FDA request, but believes it will be able to submit the additional data and information within the time period allowed by the FDA and within the schedule previously disclosed by the Company, namely in Q1 2010.
AspenBio Pharma, Inc. Files 510(k) Notification With FDA For AppyScore Test
AspenBio Pharma, Inc. announced that it has filed a Premarket Notification [510(k)] with the U.S. Food and Drug Administration (FDA) for its AppyScore Test, the first blood-based test designed as an aid in the diagnosis of human appendicitis. The 510(k) filing as submitted describes the following indication of use: The AppyScore Test is an ELISA test system that is used to quantitatively measure S100A8/A9 heterodimer complex in blood. It is an in vitro diagnostic device that is intended to be used as an adjunctive tool for the diagnosis of acute appendicitis in conjunction with additional diagnostic modalities (such as clinical exam, basic laboratory testing, imaging) in patients with abdominal pain that is suspicious for acute appendicitis.
AspenBio Pharma, Inc. AppyScore Diagnostic Blood Marker Presented
AspenBio Pharma, Inc. announced that Dr. John F. Bealer, presented a paper titled, 'S100A8/A9: A Sensitive Diagnostic Blood Marker for Acute Appendicitis. The paper demonstrated the significant sensitivity of the blood marker which underlies AppyScore's patented diagnostic technology, as expressed in the results of the company's 2008 pilot study. The test incorporates a patented assay that detects a marker in the blood associated with the inflammation seen with appendicitis, and is anticipated to be the first and only such test available in the world focused on this condition. It addresses the need for an objective, quantitative, rapid, safe, and economical diagnostic test for human appendicitis. Following the analysis of AppyScore pivotal FDA clinic trial completed earlier this year, AspenBio is advancing AppyScore towards Food and Drug Administration (FDA) application and clearance process, and plans to file a 510(k) application with the FDA by the end of the second quarter of 2009.
