Our strategy is to use non-dilutive capital wherever possible to develop our exciting platform of broad-spectrum catalytic antioxidant compounds in important unmet indications of national strategic importance. We plan to continue to leverage that capital, like the investment made by U.S. government agencies, such as NIH-NIAID and NIH CounterACT, in AEOL 10150 as a medical countermeasure, to concurrently develop these promising compounds for use in significant unmet medical indications, like oncology. We are currently doing this with AEOL 10150, where we are leveraging the potential substantial government investment in research and development of AEOL 10150 as a medical countermeasure to develop the compound in oncology indications, where it would be used in combination with radiation therapy.
We are developing a platform of a new class of broad-spectrum catalytic antioxidant compounds based on technology discovered at Duke University and National Jewish Health. These compounds, known as metalloporphyrins, scavenge reactive oxygen species ("ROS") at the cellular level, mimicking the effect of the body's own natural antioxidant enzyme superoxide dismutase ("SOD"). While the benefits of antioxidants in reducing oxidative stress are well-known, research with our compounds indicates that metalloporphyrins can be used to affect signaling via ROS at the cellular level. In addition, there is evidence that high-levels of ROS can affect gene expression and this may be modulated through the use of metalloporphyrins. We believe this could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation.
Our lead compound, AEOL 10150, is a metalloporphyrin specifically designed to neutralize reactive oxygen and nitrogen species. The neutralization of these species reduces oxidative stress, inflammation, and subsequent tissue damage-signaling cascades resulting from radiation exposure. We are leveraging the significant investment made by U.S. government agencies to develop this promising compound for use in oncology indications, where it would be used in combination with radiation therapy, and is currently in development for use as both a therapeutic and prophylactic drug.
AEOL 10150 has previously been tested in two Phase I clinical trials with no serious adverse events reported. Data have already been published showing that AEOL 10150 does not interfere with the therapeutic benefit of radiation therapy in prostate and lung cancer preclinical studies. Early next year we expect to release data showing the drug's impact, if any, when used in combination with radiation and/or chemotherapy. In mid-2011 we expect to begin Phase I/II studies in non-small cell lung cancer ("NSCLC").
AEOL 10150 is also being developed as a medical countermeasure against the pulmonary sub-syndrome of acute radiation syndrome ("Pulmonary Acute Radiation Syndrome" or "Lung-ARS") as well as the gastrointestinal sub-syndrome of acute radiation syndrome ("GI-ARS"), both caused by exposure to high levels of radiation due to a radiological or nuclear event. It is also being developed for use as a countermeasure for exposure to chemical vesicants such as chlorine gas and sulfur mustard gas. AEOL 10150 has already performed well in animal efficacy and safety studies in each of these potential indications. A significant portion of the funding for the medical countermeasure development programs to date has come from various government entities. Although our management expects this funding to continue, there is no guarantee that it will do so. We have submitted proposals to the Biomedical Advanced Research and Development Authority ("BARDA") to develop AEOL 10150 as countermeasures for both Lung-ARS and cholorine gas exposure. We are awaiting a final decision from BARDA on the contract. If the contract from BARDA is awarded, it is expected that it will fund all of the costs to bring AEOL 10150 to FDA approval for that indication.
We have two programs underway for the development of our second drug candidate, AEOL 11207, for the treatment of epilepsy and Parkinson's disease. These programs are being funded, in part, by private foundations and government grants.
PDF Presentation Feb 2011: www.aeoluspharma.com/wp-content/uploads/2010/10/Aeolus-Presentation-January-2011_Web.pdf
60,470,718 outstanding shares as of MAY 10,2011
200,000,000 shares authorized
~ 6 - 9 Million shares in the Float
as of Jan 26, 2011
Point of Contact:
CFO: Russell Skibsted
Public Company, Headquarters Location
26361 Crown Valley Pkwy., Ste. 150, Mission Viejo, CA 92691-7324, United States
(949)481-9825, (949)481-9829 fax