MISSION VIEJO, CA--(Marketwired - February 13, 2015) - Aeolus Pharmaceuticals, Inc. (
The Company reported a net loss of approximately $698,000, or $0.01 per share for the three months ended December 31, 2014. This compares to a net loss of $695,000, or $0.01 per share, for the three months ended December 31, 2013.
"During the quarter, we continued to make progress in the development of AEOL 10150 as a medical countermeasure against the pulmonary effects of Acute Radiation Syndrome ('Lung ARS') and we look forward to reaching several milestones over the next several months," stated John L. McManus, President and Chief Executive Officer. "We filed our response to the clinical hold placed on our Investigational New Drug Application ('IND') for Lung ARS by the Medical Imaging Products Division ('DMIP') of the U.S. Food and Drug Administration ('FDA') and will meet with them in March to confirm our path to initiating the phase I study of AEOL 10150 in healthy volunteers. We also expect to report the complete results from the NHP Efficacy study, as well as survival results from several mouse efficacy studies. In addition to the Lung ARS work, we expect to meet with the Oncology Division and the Respiratory Division of the FDA and then to file separate INDs to allow phase 1 studies in radiation oncology and pulmonary fibrosis. 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 December 31, 2014
Revenue for the three months ended December 31, 2014 was approximately $925,000, versus revenue of $793,000 for the three months ended December 31, 2013. The revenue is from the contract with BARDA announced on February 11, 2011. Higher revenue in 2014 reflects the timing of the initiation of program items and revenue recognition under accounting rules.
Research and development expenses increased to approximately $973,000 for the three months ended December 31, 2014, from approximately $707,000 for the three months ended December 31, 2013. The increase in 2014 expenses reflects both the timing of program items under the BARDA and expense recognition under accounting rules.
General and administrative expenses were approximately $650,000 for the three months ended December 31, 2014 compared to approximately $781,000 for the three months ended December 31, 2013. The lower expense was due to reduced stock based compensation and reduced legal expenses.
As of December 31, 2014, the Company had approximately $447,000 in cash and cash equivalents and 135,850,068 common shares outstanding. The Company had accounts receivable of $1,812,000 and accounts payable of $1,261,000 on December 31, 2014.
Aeolus has filed today with the SEC its Quarterly Report on Form 10-Q for the quarter ended December 31, 2014. 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, 2013. 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) | ||||||||||
| December 31, 2014 | September 30, 2014 | |||||||||
| ASSETS | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 447 | $ | 1,517 | ||||||
| Accounts receivable | 1,812 | 1,559 | ||||||||
| Deferred subcontractor cost | 424 | 426 | ||||||||
| Prepaid and other current assets | 65 | 46 | ||||||||
| Total current assets | 2,748 | 3,548 | ||||||||
| Investment in CPEC LLC | 32 | 32 | ||||||||
| Total assets | $ | 2,780 | $ | 3,580 | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable and accrued expenses | $ | 1,261 | $ | 1,552 | ||||||
| Deferred revenue | 441 | 443 | ||||||||
| Total current liabilities | 1,702 | 1,995 | ||||||||
| Total liabilities | 1,702 | 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 December 31, 2014 and September 30, 2014, respectively; no shares issued and outstanding as of December 31, 2014 and September 30, 2014, respectively | - | - | ||||||||
| Series B nonredeemable convertible preferred stock, 1,600,000 shares authorized as of December 31, 2014 and September 30, 2014, respectively; 526,080 shares issued and outstanding as of December 31, 2014 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 December 31, 2014 and September 30, 2014, respectively | 1,359 | 1,359 | ||||||||
| Additional paid-in capital | 184,413 | 184,223 | ||||||||
| Accumulated deficit | (184,699 | ) | (184,002 | ) | ||||||
| Total stockholders' equity | 1,078 | 1,585 | ||||||||
| Total liabilities and stockholders' equity | $ | 2,780 | $ | 3,580 | ||||||
| AEOLUS PHARMACEUTICALS, INC. | ||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
| (Unaudited) | ||||||||||
| (In thousands, except per share data) | ||||||||||
| Three Months Ended December 31, |
||||||||||
| 2014 | 2013 | |||||||||
| Revenue: | ||||||||||
| Contract revenue | $ | 925 | $ | 793 | ||||||
| Costs and expenses: | ||||||||||
| Research and development | 973 | 707 | ||||||||
| General and administrative | 650 | 781 | ||||||||
| Total costs and expenses | 1,623 | 1,488 | ||||||||
| Loss from operations | (698 | ) | (695 | ) | ||||||
| Net loss | $ | (698 | ) | $ | (695 | ) | ||||
| Net loss per weighted share attributable to common stockholders: | ||||||||||
| Basic | $ | (698 | ) | $ | (695 | ) | ||||
| Diluted | $ | (698 | ) | $ | (695 | ) | ||||
| Basic net loss per common share | $ | (0.01 | ) | $ | (0.01 | ) | ||||
| Diluted net loss per common share | $ | (0.01 | ) | $ | (0.01 | ) | ||||
| Weighted average common shares outstanding: | ||||||||||
| Basic | 135,850 | 134,550 | ||||||||
| Diluted | 135,850 | 134,550 | ||||||||
| AEOLUS PHARMACEUTICALS, INC. | |||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||||
| (Unaudited) | |||||||||||
| (In thousands) | |||||||||||
| Three Months Ended December 31, |
|||||||||||
| 2014 | 2013 | ||||||||||
| Cash flows from operating activities: | |||||||||||
| Net loss | $ | (698 | ) | $ | (695 | ) | |||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Stock-based compensation | 191 | 268 | |||||||||
| Change in assets and liabilities: | |||||||||||
| Accounts receivable | (253 | ) | (741 | ) | |||||||
| Deferred subcontractor cost | 2 | (387 | ) | ||||||||
| Prepaid and other assets | (19 | ) | 1 | ||||||||
| Accounts payable and accrued expenses | (291 | ) | 816 | ||||||||
| Deferred revenue | (2 | ) | 403 | ||||||||
| Net cash used in operating activities | (1,070 | ) | (335 | ) | |||||||
| Net decrease in cash and cash equivalents | (1,070 | ) | (335 | ) | |||||||
| Cash and cash equivalents at beginning of period | 1,517 | 869 | |||||||||
| Cash and cash equivalents at end of period | $ | 447 | $ | 534 | |||||||
Contact Information:
Contact:
John McManus
President and Chief Executive Officer
Aeolus Pharmaceuticals, Inc.
1-(949) 481-9825