MISSION VIEJO, CA--(Marketwired - May 15, 2015) - Aeolus Pharmaceuticals, Inc. (
The Company reported a net loss of approximately $712,000, or $0.01 per share for the three months ended March 31, 2015. This compares to a net loss of $437,000, or $0.00 per share, for the three months ended March 31, 2014. The Company reported a net loss of approximately $1,410,000, or $0.01 per share for the six months ended March 31, 2015. This compares to a net loss of $1,132,000, or $0.01 per share, for the six months ended March 31, 2014.
"During the quarter, we continued to make progress in the development of AEOL 10150 as both a medical countermeasure against the pulmonary effects of Acute Radiation Syndrome ("Lung ARS") and as a treatment for diseases like idiopathic pulmonary fibrosis ("IPF")," stated John L. McManus, President and Chief Executive Officer. "In March we met with the Medical Imaging Products Division ("DMIP") at the U.S. Food & Drug Administration ("FDA") to discuss the response to the clinical hold placed on our IND for Lung ARS. The meeting with DMIP greatly clarified and simplified the pathway to addressing the clinical hold and we will provide guidance to investors shortly. Also during the quarter, we received notice from the Office of Orphan Products Development at FDA granting Orphan Drug Designation for AEOL 10150 for the treatment of idiopathic pulmonary fibrosis. We intend to meet with the Respiratory Division of the FDA and then file an Investigational New Drug application ("IND") to begin human clinical trials in this indication. In addition to our work in IPF, we continued to prepare an IND for AEOL 10150 as a treatment to reduce the side effects of radiation therapy for oncology and we intend to meet with the Oncology Division at FDA to discuss that filing in the next few months. Our goal is to have clinical studies in multiple indications underway before the end of the year."
Results of Operations for the three months ended March 31, 2015
We had net loss of $712,000 and net loss of $437,000 and cash outflows from operations of $199,000 and $14,000 for the three months ended March 31, 2015 and March 31, 2014, respectively.
Revenue for the three months ended March 31, 2015 was $1,189,000, which compares to $1,438,000 for the three months ended March 31, 2014. The revenue is from the contract with the Biomedical Advanced Research and Development Authority ("BARDA"). Under the BARDA Contract, we generate contract revenue from a cost-plus fee arrangement. Revenues on reimbursable contracts are recognized as costs are incurred, which is 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.
Research and Development ("R&D") expenses increased $124,000, or 11%, to $1,297,000 for the three months ended March 31, 2015 from $1,173,000 for the three months ended March 31, 2014. The increase is primarily attributable to work related to the BARDA Contract, including the completion of the large study in non-human primates.
General and administrative ("G&A") expenses decreased $98,000, or 14%, to $604,000 for the three months ended March 31, 2015 from $702,000 for the three months ended March 31, 2014. Stock-based compensation decreased by $123,000 due to lower employee and consultant grants in the current period.
Results of Operations for the six months ended March 31, 2015
We had net losses of $1,410,000 and $1,132,000 and cash outflows from operations of $1,269,000 and $349,000 for the six months ended March 31, 2015 and March 31, 2014, respectively.
Revenue for the six months ended March 31, 2015 was $2,114,000, which compares to $2,231,000 for the six months ended March 31, 2014. The revenue is from the BARDA Contract. 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, which is 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.
Research and Development ("R&D") expenses increased $390,000, or 21%, to $2,270,000 for the six months ended March 31, 2015 from $1,880,000 for the six months ended March 31, 2014. The increase is primarily attributable to work related to the BARDA Contract.
General and administrative ("G&A") expenses decreased $229,000, or 15%, to $1,254,000 for the six months ended March 31, 2015 from $1,483,000 for the six months ended March 31, 2014 due to lower stock-based compensation.
As of March 31, 2015, the Company had approximately $248,000 in cash and cash equivalents and 135,850,068 common shares outstanding. The Company had accounts receivable of $1,807,000 and accounts payable of $1,761,000 on March 31, 2015.
Aeolus has filed today with the SEC its Quarterly Report on Form 10-Q for the quarter ended March 31, 2015. Aeolus urges its investors to read this quarterly filing as well as its Annual Report on Form 10-K, also filed with the SEC, for further details concerning the Company. The Quarterly Report on Form 10-Q and the Annual Report on Form 10-K are also available on the Company's website, at www.aolsrx.com.
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 the treatment of oncology.
AEOL 10150 has performed well in preclinical and non-clinical studies, demonstrating statistically significant survival benefit in an acute radiation-induced lung injury model, and was well-tolerated in two human clinical trials. The Company believes it could have a profound beneficial impact on people who have been exposed, or are about to be exposed, to high-doses of radiation, whether from cancer therapy or a nuclear event.
About Aeolus Pharmaceuticals
Aeolus Pharmaceuticals is developing a platform of a new class of broad-spectrum, catalytic-antioxidant compounds that protect healthy tissue from the damaging effects of radiation. Its first 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 and research programs, the Company's potential initiation of large efficacy studies in mice and NHPs, as well as a phase 1 study in healthy normal volunteers, the BARDA Contract, and the expected use of proceeds from the 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, 2014. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.
AEOLUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except per share data)
| March 31, 2015 |
September 30, 2014 | |||||||||
| ASSETS | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 248 | $ | 1,517 | ||||||
| Accounts receivable | 1,807 | 1,559 | ||||||||
| Deferred subcontractor cost | 51 | 426 | ||||||||
| Prepaids and other current assets | 110 | 46 | ||||||||
| Total current assets | 2,216 | 3,548 | ||||||||
| Investment in CPEC LLC | 32 | 32 | ||||||||
| Total assets | $ | 2,248 | $ | 3,580 | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable and accrued expenses | $ | 1,761 | $ | 1,552 | ||||||
| Deferred revenue | 53 | 443 | ||||||||
| Total current liabilities | 1,814 | 1,995 | ||||||||
| Total liabilities | 1,814 | 1,995 | ||||||||
| Commitments and Contingencies (Note F) | ||||||||||
| Stockholders' equity: | ||||||||||
| Preferred stock, $.01 par value per share, 10,000,000 shares authorized: | ||||||||||
| Series A nonredeemable convertible preferred stock, 1,250,000 shares authorized as of March 31, 2015 and September 30, 2014, respectively; no shares issued and outstanding as of March 31, 2015 and September 30, 2014, respectively | - | - | ||||||||
| Series B nonredeemable convertible preferred stock, 1,600,000 and 1,600,000 shares authorized as of March 31, 2015 and September 30, 2014, respectively; 526,080 and 526,080 shares issued and outstanding as of March 31, 2015 and September 30, 2014, respectively | 5 | 5 | ||||||||
| Common stock, $.01 par value per share, 200,000,000 shares authorized; 135,850,068 shares issued and outstanding as of March 31, 2015 and September 30, 2014, respectively | 1,359 | 1,359 | ||||||||
| Additional paid -- in capital | 184,481 | 184,223 | ||||||||
| Accumulated deficit | (185,411 | ) | (184,002 | ) | ||||||
| Total stockholders' equity | 434 | 1,585 | ||||||||
| Total liabilities and stockholders' equity | $ | 2,248 | $ | 3,580 | ||||||
AEOLUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)
| Three months Ended March 31, |
Six Months Ended March 31, |
|||||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||||
| Revenue: | ||||||||||||||||||
| Contract Revenue | $ | 1,189 | $ | 1,438 | $ | 2,114 | $ | 2,231 | ||||||||||
| Costs and expenses: | ||||||||||||||||||
| Research and development | 1,297 | 1,173 | 2,270 | 1,880 | ||||||||||||||
| General and administrative | 604 | 702 | 1,254 | 1,483 | ||||||||||||||
| Total costs and expenses | 1,901 | 1,875 | 3,524 | 3,363 | ||||||||||||||
| Loss from operations | (712 | ) | (437 | ) | (1,410 | ) | (1,132 | ) | ||||||||||
| Net loss | $ | (712 | ) | $ | (437 | ) | $ | (1,410 | ) | $ | (1,132 | ) | ||||||
| Net loss per weighted share attributable to common stockholders: | ||||||||||||||||||
| Basic (Note D) | $ | (0.01 | ) | $ | 0.00 | $ | (0.01 | ) | $ | (0.01 | ) | |||||||
| Diluted (Note D) | $ | (0.01 | ) | $ | 0.00 | $ | (0.01 | ) | $ | (0.01 | ) | |||||||
| Weighted average common shares outstanding: | ||||||||||||||||||
| Basic | 135,850 | 134,550 | 135,850 | 134,550 | ||||||||||||||
| Diluted | 135,850 | 134,550 | 135,850 | 134,550 | ||||||||||||||
AEOLUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
| Six Months Ended March 31, |
|||||||||||
| 2015 | 2014 | ||||||||||
| Cash flows from operating activities: | |||||||||||
| Net loss | $ | (1,410 | ) | $ | (1,132 | ) | |||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Stock-based compensation | 259 | 463 | |||||||||
| Change in assets and liabilities: | |||||||||||
| Accounts receivable | (248 | ) | (1,468 | ) | |||||||
| Deferred subcontractor cost | 375 | (746 | ) | ||||||||
| Prepaid and other assets | (64 | ) | (57 | ) | |||||||
| Accounts payable and accrued expenses | 209 | 1,815 | |||||||||
| Deferred revenue | (390 | ) | 776 | ||||||||
| Net cash used in operating activities | (1,269 | ) | (349 | ) | |||||||
| Net decrease in cash and cash equivalents | (1,269 | ) | (349 | ) | |||||||
| Cash and cash equivalents at beginning of period | 1,517 | 869 | |||||||||
| Cash and cash equivalents at end of period | $ | 248 | $ | 520 | |||||||
Contact Information:
Contact:
John McManus
President and Chief Executive Officer
Aeolus Pharmaceuticals, Inc.
1-(949) 481-9825