AEOL 20415 Protects Lungs Against Infection in Animal Model of Cystic Fibrosis

MISSION VIEJO, CA--(Marketwired - March 15, 2017) -

• TREATMENT WITH AEOL 20415 REDUCED INFECTION, IMPROVED BODY WEIGHT AND REDUCED PRESENCE OF WHITE BLOOD CELLS, MACROPHAGES AND LYMPHOCYTES
• DETAILED RESULTS TO BE SUBMITTED FOR PUBLICATION

Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection announced that a study completed at National Jewish Health showed that AEOL 20415 protects the lungs in a mouse model of cystic fibrosis. The studies were performed by Brian Day, PhD, Vice Chair of Research at National Jewish Health. Aeolus is a biotechnology company focused on developing compounds to address unmet medical needs in both traditional as well as governmental markets. AEOL 20415 has demonstrated potential as both a treatment for cystic fibrosis as well as antibiotic-resistant bacteria. Development of novel treatments for antibiotic-resistant bacteria has been a major priority at both the National Institutes of Health ("NIH") and the Biomedical Advanced Research and Development Authority ("BARDA").

"This study confirms previous in-vitro studies indicating that AEOL 20415 is unique because it augments the body's natural host defense system for fighting bacterial infection while limiting inflammation," stated Brian Day, PhD, Vice Chair of Research at National Jewish Health. "Currently available anti-inflammatory drugs work by suppressing the immune system, which can be counterproductive during active infection. AEOL 20415 has demonstrated efficacy in killing drug resistant clinical strains of Burkholderia cepacia and Pseudomonas aeruginosa isolated from cystic fibrosis patients and improving bacterial clearance while diminishing lung inflammation."

Aeolus believes that AEOL 20415 may have applications as a broad spectrum anti-microbial and in several large medical indications. As an anti-microbial, the compound has demonstrated the ability to kill pathogens, including antibiotic-resistant strains, while dampening inflammation caused by immune response to both viral and bacterial infections. In some infectious diseases, such as virulent strains of influenza virus, inflammation from the body's normal immune response can increase lethality. Aeolus believes that the combination of anti-microbial and anti-inflammatory activity exhibited by the new compounds could be particularly beneficial in treating these types of infectious threats.

"AEOL 20415 shows tremendous promise as both a potential treatment for cystic fibrosis and as a solution to the growing problem of drug-resistant bacteria. We look forward to sharing this animal data with potential collaborators in industry and the government in our continuing efforts to address unmet medical needs through public-private partnerships, such as those we have used to develop our lead compound AEOL 10150," said John McManus, Chief Executive Officer of Aeolus. "The combination of anti-microbial and anti-inflammatory action of AEOL 20415 makes it particularly effective in addressing antibiotic-resistant infectious disease threats, as well traditional indications like cystic fibrosis."

About Aeolus Pharmaceuticals

Aeolus Pharmaceuticals is developing a platform of novel compounds for use in biodefense, fibrosis, oncology, infectious diseases and diseases of the central nervous system. Its most advanced compound, AEOL 10150, is being developed, with funding by the US Department of Health and Human Services, as a medical countermeasure 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, including the contract with BARDA valued, with options, at up to $118.4 million, to efficiently develop the compound for use in oncology. 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, development strategies and research programs, including the Company's initiation or potential initiation of pre-clinical development as well as clinical trials, including a phase 1 study in pulmonary fibrosis patients. 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 and obtaining regulatory approval; the imposition or continuation of clinical holds on development projects; 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; competition from other biopharmaceutical companies; and whether BARDA exercises one or more additional options under the its contract with Aeolus. 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, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.