MISSION VIEJO, CA--(Marketwired - December 21, 2016) - Aeolus Pharmaceuticals, Inc. (AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection announced today financial results for the three months and twelve months ended September 30, 2016.
Key Fiscal Year 2016 Operational Accomplishments
Received clearance from the U.S. Food & Drug Administration ("FDA") to initiate Phase I studies with AEOL 10150 in healthy normal volunteers
Initiated work to enable an Investigational New Drug ("IND") application in AEOL 11114 for the treatment of Parkinson's disease
Published data in the journal Toxicological Sciences demonstrating that treatment with 10150 after exposure to lethal doses of sulfur mustard gas
Improved survival at 48 hours from 36% to 88%
Increased blood oxygen saturation by more than 10 percent
Improved clinical scores of lung health by 57 percent
Decreased airway casts by 69 percent
Restored levels of TNF-a, IL-6, KC/GRO (rat analog of human IL-8) and IL-1b, which are elevated significantly after exposure to sulfur mustard gas, to control levels
Restored levels of TGF-beta1 to control levels
Improved survival at 48 hours from 36% to 88%
Increased blood oxygen saturation by more than 10 percent
Improved clinical scores of lung health by 57 percent
Decreased airway casts by 69 percent
Restored levels of TNF-a, IL-6, KC/GRO (rat analog of human IL-8) and IL-1b, which are elevated significantly after exposure to sulfur mustard gas, to control levels
Restored levels of TGF-beta1 to control levels
Announced positive data from a study using AEOL 10150 to treat exposure to lethal doses of sulfur mustard gas demonstrating a doubling of survival at 28 days
$30.8 million in total funding options exercised as of September 30, 2016 under the Company's advanced development contract with the Biomedical Advanced Research and Development Authority ("BARDA")
Up to $87.6 million in additional funding options exercisable over the remainder of the BARDA contract
"Significant progress in the development of AEOL 10150 for the lung effects of acute radiation exposure ("Lung-ARS") and Idiopathic Pulmonary Fibrosis ("IPF") and AEOL 11114 for Parkinson's disease was made during fiscal year 2016. We completed the work required to allow us to move into human safety studies and received approval from the FDA to initiate a Phase I study in healthy normal volunteers, which we plan to begin during the first quarter of calendar of 2017," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "We also completed the manufacturing optimization and formulation development work for our Parkinson's candidate, AEOL 11114 during fiscal 2016, and hope to complete the pre-clinical work necessary to file and IND and begin human studies of that compound during fiscal 2017."
Financial Results
The Company reported a net loss of $3,558,000 for the fiscal year ended September 30, 2016, versus a net loss of $2,628,000 for the fiscal year ended September 30, 2015.
Revenue for the fiscal year ended September 30, 2016 was approximately $2,076,000, compared to $3,111,000 revenue for the fiscal year ended September 30, 2015. The revenue is from the cost-plus contract with BARDA for the development of AEOL 10150 as a medical countermeasure for the pulmonary and delayed effects of acute radiation exposure. Since being awarded the BARDA Contract, we generate contract revenue from a cost-plus fee arrangement. Revenues on reimbursable contracts are recognized as costs are incurred, based on allowable costs incurred during the period, plus any recognizable earned fee. We consider fixed fees under cost-plus fee contracts to be earned in proportion to the allowable costs incurred in performance of the contract. Revenue was higher in the prior year primarily due to the timing of work related to the BARDA contract.
On May 25, 2016, we announced that BARDA had exercised a Contract Modification worth approximately $0.4 million. The purpose of the Modification was to provide funding to complete a pharmacometric analysis of data from all completed animal efficacy studies of 10150 to determine optimal dose, dose frequency and duration of treatment. The total contract value exercised as of September 30, 2016 is approximately $30.8 million. We may receive up to an additional $87.6 million in options exercisable over the remainder of the BARDA Contract. Options are exercised based on the progress of the development program, including the completion of clinical trials or manufacturing tasks under previously exercised options.
Research and development expenses decreased by $628,000, or 18%, to approximately $2,881,000 for the fiscal year ended September 30, 2016 from approximately $3,509,000 for the fiscal year ended September 30, 2015. R&D expenses were lower during the fiscal year ended September 30, 2016 versus September 30, 2015 due to the timing of work related to the BARDA Contract.
G&A expenses increased approximately $240,000, or 11%, to approximately $2,468,000 for the fiscal year ended September 30, 2016 from about $2,228,000 for the fiscal year ended September 30, 2015. Legal expense increased by about $102,000 as a result of higher SEC filing and financing costs. Board of Director fees increased by about $56,000. The Company had previously suspended cash payments Director fees in 2008.
For the fourth quarter of FY 2016, total revenues were $546,000 as compared to $934,000 in the fourth quarter of FY 2015. Net loss for the fourth quarter in FY 2016 was $1,024,000 or ($0.00/share) as compared to $434,000 or ($0.00/share) in the fourth quarter of FY2015.
Aeolus has filed today with the SEC its Annual Report on Form 10-K for the fiscal year ended September 30, 2016. Aeolus urges its investors to read this quarterly filing as well as its amended Annual Report on Form 10-K/A, also filed with the SEC, for further details concerning the Company. The Quarterly Report on Form 10-Q and the amended Annual Report on Form 10-K/A are also available on the Company's website, at www.aolsrx.com.
Key Fiscal Year 2016 Operational Accomplishments
Received clearance from the U.S. Food & Drug Administration ("FDA") to initiate Phase I studies with AEOL 10150 in healthy normal volunteers
Initiated work to enable an Investigational New Drug ("IND") application in AEOL 11114 for the treatment of Parkinson's disease
Published data in the journal Toxicological Sciences demonstrating that treatment with 10150 after exposure to lethal doses of sulfur mustard gas
Improved survival at 48 hours from 36% to 88%
Increased blood oxygen saturation by more than 10 percent
Improved clinical scores of lung health by 57 percent
Decreased airway casts by 69 percent
Restored levels of TNF-a, IL-6, KC/GRO (rat analog of human IL-8) and IL-1b, which are elevated significantly after exposure to sulfur mustard gas, to control levels
Restored levels of TGF-beta1 to control levels
Improved survival at 48 hours from 36% to 88%
Increased blood oxygen saturation by more than 10 percent
Improved clinical scores of lung health by 57 percent
Decreased airway casts by 69 percent
Restored levels of TNF-a, IL-6, KC/GRO (rat analog of human IL-8) and IL-1b, which are elevated significantly after exposure to sulfur mustard gas, to control levels
Restored levels of TGF-beta1 to control levels
Announced positive data from a study using AEOL 10150 to treat exposure to lethal doses of sulfur mustard gas demonstrating a doubling of survival at 28 days
$30.8 million in total funding options exercised as of September 30, 2016 under the Company's advanced development contract with the Biomedical Advanced Research and Development Authority ("BARDA")
Up to $87.6 million in additional funding options exercisable over the remainder of the BARDA contract
"Significant progress in the development of AEOL 10150 for the lung effects of acute radiation exposure ("Lung-ARS") and Idiopathic Pulmonary Fibrosis ("IPF") and AEOL 11114 for Parkinson's disease was made during fiscal year 2016. We completed the work required to allow us to move into human safety studies and received approval from the FDA to initiate a Phase I study in healthy normal volunteers, which we plan to begin during the first quarter of calendar of 2017," stated John L. McManus, President and Chief Executive Officer of Aeolus Pharmaceuticals, Inc. "We also completed the manufacturing optimization and formulation development work for our Parkinson's candidate, AEOL 11114 during fiscal 2016, and hope to complete the pre-clinical work necessary to file and IND and begin human studies of that compound during fiscal 2017."
Financial Results
The Company reported a net loss of $3,558,000 for the fiscal year ended September 30, 2016, versus a net loss of $2,628,000 for the fiscal year ended September 30, 2015.
Revenue for the fiscal year ended September 30, 2016 was approximately $2,076,000, compared to $3,111,000 revenue for the fiscal year ended September 30, 2015. The revenue is from the cost-plus contract with BARDA for the development of AEOL 10150 as a medical countermeasure for the pulmonary and delayed effects of acute radiation exposure. Since being awarded the BARDA Contract, we generate contract revenue from a cost-plus fee arrangement. Revenues on reimbursable contracts are recognized as costs are incurred, based on allowable costs incurred during the period, plus any recognizable earned fee. We consider fixed fees under cost-plus fee contracts to be earned in proportion to the allowable costs incurred in performance of the contract. Revenue was higher in the prior year primarily due to the timing of work related to the BARDA contract.
On May 25, 2016, we announced that BARDA had exercised a Contract Modification worth approximately $0.4 million. The purpose of the Modification was to provide funding to complete a pharmacometric analysis of data from all completed animal efficacy studies of 10150 to determine optimal dose, dose frequency and duration of treatment. The total contract value exercised as of September 30, 2016 is approximately $30.8 million. We may receive up to an additional $87.6 million in options exercisable over the remainder of the BARDA Contract. Options are exercised based on the progress of the development program, including the completion of clinical trials or manufacturing tasks under previously exercised options.
Research and development expenses decreased by $628,000, or 18%, to approximately $2,881,000 for the fiscal year ended September 30, 2016 from approximately $3,509,000 for the fiscal year ended September 30, 2015. R&D expenses were lower during the fiscal year ended September 30, 2016 versus September 30, 2015 due to the timing of work related to the BARDA Contract.
G&A expenses increased approximately $240,000, or 11%, to approximately $2,468,000 for the fiscal year ended September 30, 2016 from about $2,228,000 for the fiscal year ended September 30, 2015. Legal expense increased by about $102,000 as a result of higher SEC filing and financing costs. Board of Director fees increased by about $56,000. The Company had previously suspended cash payments Director fees in 2008.
For the fourth quarter of FY 2016, total revenues were $546,000 as compared to $934,000 in the fourth quarter of FY 2015. Net loss for the fourth quarter in FY 2016 was $1,024,000 or ($0.00/share) as compared to $434,000 or ($0.00/share) in the fourth quarter of FY2015.
Aeolus has filed today with the SEC its Annual Report on Form 10-K for the fiscal year ended September 30, 2016. Aeolus urges its investors to read this quarterly filing as well as its amended Annual Report on Form 10-K/A, also filed with the SEC, for further details concerning the Company. The Quarterly Report on Form 10-Q and the amended Annual Report on Form 10-K/A are also available on the Company's website, at www.aolsrx.com.
