Aeolus Announces Removal of FDA Clinical Hold on AEOL 10150; Initiation of Phase 1 Study in Healthy Volunteers Planned for 2nd Quarter 2016

MISSION VIEJO, CA--(Marketwired - February 22, 2016) -  Aeolus Pharmaceuticals, Inc.(OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection announced today that it has received notice that the U.S. Food & Drug Administration ("FDA") has removed the clinical hold on the Company's Investigational New Drug application for AEOL 10150 ("10150") as a treatment for the lung and delayed effects of acute radiation exposure ("Lung-ARS"). The lifting of the clinical hold allows the Company to initiate its planned human safety study in healthy normal volunteers.

"We thank the FDA for its continued thoughtful review and guidance in the development of 10150 as a medical countermeasure ("MCM") for Lung-ARS," stated John L. McManus, President and Chief Executive Officer. "The removal of the clinical hold will allow us to move forward with a Phase 1 safety study in healthy normal volunteers, which we hope to begin in the 2^nd quarter. We are also grateful to our development partner, the Biomedical Advanced Research and Development Authority ("BARDA") for their continued support and valuable input into our response to the FDA. With the clinical hold removed, we look forward to further advancing the development of 10150 as a MCM for this unmet medical need." 

10150 is being developed as a MCM for Lung-ARS under a contract valued at up to $118.4 million with the BARDA, a division of the U.S. Department of Health and Human Services. In multiple studies, 10150 has demonstrated both survival advantage and protection of healthy lung function in animals subjected to lethal doses of acute radiation. There are no current treatments for Lung-ARS. 

10150 has been awarded Orphan Drug status by the Office of Orphan Products Development of the FDA for Lung ARS. The Company intends to file a pre-Emergency Use Authorization application with the FDA for the use of 10150 in Lung-ARS upon the completion of the planned safety program.

About AEOL 10150

AEOL 10150 is a broad-spectrum catalytic antioxidant 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. AEOL 10150 may have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation in a nuclear event or the treatment of cancer.

AEOL 10150 has performed well in animal safety studies, was well tolerated in two human clinical trials and has demonstrated statistically significant survival efficacy in multiple Radiation-Induced Lung Fibrosis ("Lung ARS") studies in animals. Aeolus has received "Orphan Drug" designation for the use of AEOL 10150 in treating Lung ARS and Idiopathic Pulmonary Fibrosis and has an IND on file to allow for human safety testing of the compound in healthy volunteers. AEOL 10150 is also currently in development for use in Idiopathic Pulmonary Fibrosis and as both a therapeutic and prophylactic drug in cancer patients.

About Aeolus Pharmaceuticals

Aeolus Pharmaceuticals is developing a platform of novel compounds, known as metalloporphyrins, for use in biodefense, fibrosis, oncology, infectious disease and diseases of the central nervous system. Its lead compound, AEOL 10150, is being developed, with funding from the US Department of Health and Human Services, as a MCM against chemical and radiological weapons, where its initial target indications are as a protective agent against the effects of acute radiation syndrome and delayed effects of acute radiation exposure. Aeolus' strategy is to leverage the substantial investment in toxicology, manufacturing, and preclinical and clinical studies made by US Government agencies in AEOL 10150 to develop the compound for the treatment of lung fibrosis, including idiopathic pulmonary fibrosis ("IPF") and as a treatment to reduce side effects caused by radiation toxicity and improve local tumor control in cancer therapy. The Company is also developing AEOL 11114 as a treatment for Parkinson's Disease and AEOL 20415 as a treatment for cystic fibrosis and diseases that have developed a resistance to existing antibiotic and anti-viral therapies. For more information, please visit Aeolus's corporate website at www.aolsrx.com.

Forward-Looking Statements

The statements in this press release that are not purely statements of historical fact are forward-looking statements. Such statements include, but are not limited to, those relating to Aeolus' product candidates, as well as its proprietary technologies and research programs, a potential phase 1 study in healthy normal volunteers, the BARDA Contract, and the expected use of proceeds from the recent financing. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Aeolus' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Important factors that could cause results to differ include risks associated with uncertainties of progress and timing of clinical trials, scientific research and product development activities, difficulties or delays in development, testing, obtaining regulatory approval, the need to obtain funding for pre-clinical and clinical trials and operations, the scope and validity of intellectual property protection for Aeolus' product candidates, proprietary technologies and their uses, and competition from other biopharmaceutical companies, and whether BARDA exercises one or more additional options under the BARDA Contract. Certain of these factors and others are more fully described in Aeolus' filings with the Securities and Exchange Commission, including, but not limited to, Aeolus' Annual Report on Form 10-K for the year ended September 30, 2015. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.