MISSION VIEJO, CA--(Marketwire - Feb 13, 2012) - Aeolus Pharmaceuticals, Inc. (
- $2.2 million in revenue
- Meeting to request exercise of additional contract options scheduled for February 14, 2012
Aeolus Pharmaceuticals, Inc. (
The Company reported a net profit of approximately $2,977,000, or $0.05 per share, which includes a non-cash adjustment of approximately $3,688,000 related to decreases in the fair value of warrants that are included as a component of other income (expenses) in the statement of operations, for the three months ended December 31, 2011, compared to a net loss of $7,620,000, or $0.13 per share, which includes a non-cash charge of approximately $7,202,000 related to increases in the fair value of warrants that are included as a component of other income (expenses) in the statement of operations, for the three months ended December 31, 2010.
"We have completed the first year of our five year contract with BARDA, and our team has delivered key milestones such as developing and validating murine and NHP models for lung acute radiation syndrome, improving our manufacturing processes, enhancing our understanding of the mechanism of action of AEOL 10150 and initiating dose finding studies in mice," stated John L. McManus, President and Chief Executive Officer. "We look forward to BARDA's decision on additional contract options, and hope to initiate large murine and NHP efficacy studies, as well as a Phase 1 study in healthy human volunteers."
Revenue for the three months ended December 31, 2011 was approximately $2,215,000, which compares to zero revenue for the three months ended December 31, 2010. The revenue is from the collaboration with BARDA announced on February 11, 2011.
Research and development expenses increased about $1,880,000 to approximately $2,077,000 for the three months ended December 31, 2011, from approximately $190,000 for the three months ended December 31, 2010. The increase is primarily attributable to work related to the BARDA Contract.
General and administrative expenses increased about $306,000, or 55%, to approximately $856,000 for the three months ended December 31, 2011 from approximately $550,000 for the three months ended December 31, 2010. The increase is primarily attributable to work related to the BARDA Contract.
As of December 31, 2011, the Company had approximately $1,186,000 in cash and cash equivalents and 60,470,718 common shares outstanding.
Aeolus is filing today with the SEC its Quarterly Report on Form 10-Q for the quarter ended December 31, 2011. 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 http://www.aeoluspharma.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 could 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 already performed well in preclinical and non-clinical studies, was well-tolerated in two human clinical trials, and has demonstrated statistically significant survival efficacy in an acute radiation-induced lung injury model. 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 new class of catalytic antioxidant compounds that protects healthy tissue from the damaging effects of radiation. Its first compound, AEOL 10150, is being developed for oncology indications, where it is used in combination with radiation therapy. It is also being developed, with funding by the US Government, 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.
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, and the BARDA Contract. 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' amended Annual Report on Form 10-K/A for the year ended September 30, 2010. 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 | ||||||||||
| (In thousands, except per share data) | ||||||||||
| December 31, 2011 | September 30, 2011 | |||||||||
| (Unaudited) | ||||||||||
| ASSETS | ||||||||||
| Current assets: | ||||||||||
| Cash and cash equivalents | $ | 1,186 | $ | 518 | ||||||
| Accounts receivable | 1,500 | 1,677 | ||||||||
| Prepaids and other current assets | 56 | 63 | ||||||||
| Total current assets | 2,742 | 2,258 | ||||||||
| Investment in CPEC LLC | 32 | 32 | ||||||||
| Total assets | $ | 2,774 | $ | 2,290 | ||||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||||
| Current liabilities: | ||||||||||
| Accounts payable and accrued expenses | $ | 3,142 | $ | 2,144 | ||||||
| Total current liabilities | 3,142 | 2,144 | ||||||||
| Warrant liability | 19,717 | 23,405 | ||||||||
| Total liabilities | 22,859 | 25,549 | ||||||||
| Commitments and contingencies (Notes E and H) | ||||||||||
| Stockholders' deficit: | ||||||||||
| Preferred stock, $.01 par value per share, 10,000,000 shares authorized: | ||||||||||
| Series B nonredeemable convertible preferred stock, 1,600,000 and 600,000 shares authorized as of December 31, 2011 and September 30, 2011, respectively; 526,080 and 526,080 shares issued and outstanding as of December 31, 2011 and September 30, 2011, respectively | 5 | 5 | ||||||||
| Common stock, $.01 par value per share, 200,000,000 shares authorized; 60,470,718 and 60,470,718 shares issued and outstanding as of December 31, 2011 and September 30, 2011, respectively | 605 | 605 | ||||||||
| Additional paid-in capital | 158,740 | 158,543 | ||||||||
| Accumulated deficit | (179,435 | ) | (182,412 | ) | ||||||
| Total stockholders' deficit | (20,085 | ) | (23,259 | ) | ||||||
| Total liabilities and stockholders' deficit | $ | 2,774 | $ | 2,290 | ||||||
| AEOLUS PHARMACEUTICALS, INC. | ||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
| (Unaudited) | ||||||||||
| (In thousands, except per share data) | ||||||||||
| Three Months Ended December 31, |
||||||||||
| 2011 | 2010 | |||||||||
| Revenue: | ||||||||||
| Contract revenue | $ | 2,215 | $ | -- | ||||||
| Costs and expenses: | ||||||||||
| Research and development | 2,070 | 190 | ||||||||
| General and administrative | 856 | 550 | ||||||||
| Total costs and expenses | 2,926 | 740 | ||||||||
| Loss from operations | (711 | ) | (740 | ) | ||||||
| Non-cash financing charges and change in fair value of warrants (Notes D, E and F) | 3,688 |
(7,202 |
) | |||||||
| Interest income (expense), net | -- | (15 | ) | |||||||
| Other income (expense), net | -- | 337 | ||||||||
| Net income (loss) | $ | 2,977 | $ | (7,620 | ) | |||||
| Net income (loss) per weighted share attributable to common stockholders: | ||||||||||
| Basic | $ | 0.05 | $ | (0.13 | ) | |||||
| Diluted | $ | 0.04 | $ | (0.13 | ) | |||||
| Weighted average common shares outstanding: | ||||||||||
| Basic | 60,471 | 57,026 | ||||||||
| Diluted | 80,006 | 57,026 | ||||||||
| AEOLUS PHARMACEUTICALS, INC. | |||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||||
| (Unaudited) | |||||||||||
| (In thousands) | |||||||||||
| Three Months Ended December 31, |
|||||||||||
| 2011 | 2010 | ||||||||||
| Cash flows from operating activities: | |||||||||||
| Net income (loss) | $ | 2,977 | $ | (7,620 | ) | ||||||
| Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | |||||||||||
| Stock-based compensation | 197 | 187 | |||||||||
| Change in fair value of warrants | (3,688 | ) | 6,645 | ||||||||
| Noncash exercise of warrants | -- | 169 | |||||||||
| Noncash interest and warrant costs | -- | 382 | |||||||||
| Change in assets and liabilities: | |||||||||||
| Accounts receivable | 177 | -- | |||||||||
| Prepaid and other assets | 7 | 11 | |||||||||
| Accounts payable and accrued expenses | 998 | (291 | ) | ||||||||
| Net cash provided by (used in) operating activities | 668 | (517 | ) | ||||||||
| Cash flows provided by financing activities: | |||||||||||
| Proceeds from issuance of common stock and warrants | -- | 1,000 | |||||||||
| Costs related to the issuance of common stock and warrants | -- | (13 | ) | ||||||||
| Proceeds from exercise of warrants | -- | 42 | |||||||||
| Net cash provided by financing activities | -- | 1,029 | |||||||||
| Net increase in cash and cash equivalents | 668 | 512 | |||||||||
| Cash and cash equivalents at beginning of period | 518 | 2,355 | |||||||||
| Cash and cash equivalents at end of period | $ | 1,186 | $ | 2,867 | |||||||
Contact Information:
Contact:
Russell Skibsted
Sr. Vice President and Chief Financial Officer
Aeolus Pharmaceuticals, Inc.
1-(949) 481-9825