Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against fibrosis, inflammation, nerve damage and infection, reported financial results for the nine months ended June 30, 2016 (Press release, Aeolus, AUG 15, 2016, View Source [SID:1234514588]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The Company reported a net loss of approximately $872,000, or $0.01 per share for the three months ended June 30, 2016. This compares to a net loss of approximately $784,000, or $0.01 per share for the three months ended June 30, 2015. For the nine months ended June 30, 2016, the Company reported a net loss of approximately $5,021,000, or $0.03 per share. This compares to a net loss of approximately $2,194,000, or $0.02 per share for the nine months ended June 30, 2015. The increase in net loss during the nine months ended June 30, 2016 was primarily attributable to a $2,486,000 non-cash expense related to a deemed dividend for the Company’s Series C Preferred Stock. The net operating loss for the nine months ended June 30, 2016 was $2,250,000 or $0.02 per share.
"With the work completed this quarter and over the term of our partnership with BARDA, we are on the brink of launching the clinical development of AEOL 10150. Thanks to the support of the BARDA Contract, we have reduced the cost of manufacturing AEOL 10150 by 90 percent, manufactured pilot scale GMP batches and, this past quarter, extended stability out to 3 years for the API and 2 years for the final drug product," stated John L. McManus, President and Chief Executive Officer. "Over the next two quarters, we anticipate filing INDs and initiating clinical studies in Idiopathic Pulmonary Fibrosis and cancer radiation therapy, which, in addition to launching our development efforts in two important commercial indications, will also provide the initial human safety data required for our Lung ARS medical countermeasure development program funded by BARDA."
Results of Operations for the Three Months Ended June 30, 2016
Revenue for the three months ended June 30, 2016 was approximately $660,000, which compares to approximately $63,000 for the three months ended June 30, 2015. The revenue is from the BARDA Contract. Higher revenue in 2016 reflects the timing of the initiation of program items and revenue recognition under accounting rules. 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 expenses increased to approximately $904,000 for the three months ended June 30, 2016 from approximately $269,000 for the three months ended June 30, 2015. The increase is primarily attributable to the timing of work related to the BARDA Contract.
General and administrative expenses increased to approximately $628,000 for the three months ended June 30, 2016 from approximately $578,000 for the three months ended June 30, 2015. The increase is primarily attributable to increased investor relations costs and legal fees.
Results of Operations for the Nine Months Ended June 30, 2016
Revenue for the nine months ended June 30, 2016 was approximately $1,530,000, which compares to approximately $2,177,000 for the nine months ended June 30, 2015. The revenue is from the BARDA Contract. Lower revenue in 2016 reflects the timing of the initiation of program items and revenue recognition under accounting rules.
Research and development expenses decreased to approximately $1,897,000 for the nine months ended June 30, 2016 from approximately $2,539,000 for the nine months ended June 30, 2015. The decrease is primarily attributable to the timing of work related to the BARDA Contract.
General and administrative expenses increased to approximately $1,883,000 for the nine months ended June 30, 2016 from approximately $1,832,000 for the nine months ended June 30, 2015 due to higher legal fees, investor relations cost and insurance premiums.
As of June 30, 2016, the Company had approximately $3,756,000 in cash and cash equivalents and 152,085,825 common shares outstanding. The Company had accounts receivable of $742,000 and accounts payable of $661,000 on June 30, 2016.
Aeolus has filed today with the SEC its Quarterly Report on Form 10-Q for the quarter ended June 30, 2016. 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 animal safety studies, was well tolerated in two human clinical trials and has demonstrated statistically significant survival efficacy in multiple Radiation-Induced Lung Fibrosis ("Lung ARS") studies in animals. 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. Aeolus has received "Orphan Drug" designation for the use of AEOL 10150 in treating Lung ARS and Idiopathic Pulmonary Fibrosis and has filed an IND to allow for human safety testing of the compound in healthy volunteers. AEOL 10150 is also currently in development for use in Idiopathic Pulmonary Fibrosis and as both a therapeutic and prophylactic drug in cancer patients.