Welcome!

Microsoft Cloud Authors: Pat Romanski, Lori MacVittie, Andreas Grabner, Jim Kaskade, John Basso

News Feed Item

Aeolus Pharmaceuticals Announces Fiscal Year 2012 Results

MISSION VIEJO, CA -- (Marketwire) -- 01/02/13 -- Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company leveraging significant government funding to develop a platform of novel compounds in oncology and biodefense, announced today financial results for the three months and twelve months ended September 30, 2012.

2012 Key Operational Accomplishments

  • No-cost extension & modification of Biomedical Advanced Research and Development Authority (BARDA) base year contract

  • BARDA exercised second year contract options worth over $9.1 million

  • Several publications of key data, including data demonstrating that AEOL 10150 reduced lung damage after Neupogen® treatment (current standard of care for Heme-ARS) following radiation exposure, and to reduce oxidative stress and Nerve damage following exposure to nerve agents

  • Reported significant improvements in the methods for producing AEOL 10150 Bulk Drug Substance, which are expected to reduce the cost of goods by more than 80 percent

  • Shored-up balance sheet with additional cash

  • Presented data on AEOL 11207, demonstrating a significant decrease in both the frequency and duration of spontaneous seizures; an increase in average life span; and protecting against neuronal death

  • Reported positive results from pre-IND meeting with FDA where there agency agreed with the animal models and to be used under the Lung-ARS development program and provided input on the Company's phase 1 Human Safety study design.

2012 Key Financial Results

Total revenues for FY 2012 were $7.3 million as compared to $4.8 million in FY2011. Net income was $1.7 million, or $0.03 per basic share, which includes a non-cash gain of approximately $4.1 million related to decreases in the fair value of the warrants, for the fiscal year ended September 30, 2012, as compared to a gain of $0.3 million, or $0.01 per basic share, which includes a charge of approximately $3.9 million related to increases in the fair value of the warrants, for the fiscal year ended September 30, 2011. As of September 30, 2012, the Company had cash and cash equivalents of $281,000.

For the fourth quarter FY 2012, total revenues were $1.4 million as compared to $2.1 million in 2011. Net loss for the fourth quarter in FY 2012 was $7.1 million, which includes a loss of approximately $6.6 million related to increases in the fair value of the warrants, as compared to $2.1 million, which includes a gain of approximately $1.1 million related to decreases in the fair value of the warrants, in the fourth quarter of FY 2011.

The warrant liability and revaluations have not and will not have any impact on the Company's working capital, liquidity or business operations. The Company's outstanding warrants will continue to be revalued at each balance sheet date, which could result in significant and unpredictable changes to our reported liabilities and significant additional gains or losses charged to the statement of operations for each period regardless of any changes to the Company's working capital, liquidity or business operations.

The increase in research and development expense reflects the acceleration of our Pulmonary Acute Radiation Syndrome ("Lung-ARS") program related to the execution of our contract with BARDA in 2012. We currently have eleven research and development programs in progress: seven programs involving AEOL 10150 as a medical countermeasure against the effects of sulfur mustard gas on the skin and lungs, chlorine gas on the lungs, phosgene gas on the lungs, against the effects of radiation on the lungs and on the gastro-intestinal tract, against the effects of nerve agents, two programs focused on AEOL 11207 and several other compounds as potential treatments for Parkinson's disease and epilepsy, one program studying another one of our compounds, AEOL 10171 (Hexyl), as a protectant against radiation exposure and one program studying AEOL 10150 as a treatment for cancer.

"During fiscal year 2012, we continued to take major steps forward in the development of AEOL 10150, at minimal cost to our shareholders, based on the support of our medical countermeasure development program partners: BARDA, NIH-NIAID and NIH CounterACT," stated John L. McManus, President and Chief Executive Officer. "We look forward to 2013, when we expect to request the exercise of additional options under the BARDA contract, and report critical data in efficacy and safety that we believe will position AEOL 10150 for potential procurement by BARDA for the Strategic National Stockpile."

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 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 for oncology indications, where it is used in combination with radiation therapy. It is also 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.aeoluspharma.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, proprietary technologies, and current and future research and development programs, as well as Aeolus' contract with BARDA. 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, competition from other biopharmaceutical companies, and Aeolus' contract with BARDA, including whether Aeolus will continue to receive funding under the 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, 2012. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.


              CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
                   (In thousands, except per share data)

                                  Three Months Ended    Twelve Months Ended
                                     September 30,         September 30,
                                 --------------------  --------------------
                                    2012       2011       2012       2011
                                 ---------  ---------  ---------  ---------
Revenue

Contract Revenue                 $   1,399  $   2,124  $   7,293  $   4,821

Costs and expenses:
  Research and development           1,245      2,010      6,468      5,055
  General and administrative           651      1,122      3,196      3,668
                                 ---------  ---------  ---------  ---------
    Total costs and expenses         1,896      3,132      9,664      8,723
                                 ---------  ---------  ---------  ---------

Loss from operations                  (497)    (1,008)    (2,371)    (3,902)
Interest income (expense)                -          -          -        (21)
Warrant liability charges           (6,609)    (1,141)     4,069      3,887
Other Income (Expense)                   -          -          -        335
                                 ---------  ---------  ---------  ---------

Net Income (loss)                $  (7,106) $  (2,149) $   1,698  $     299
                                 =========  =========  =========  =========

Net loss per weighted share
 attributable to common
 stockholders:
Basic                            $   (0.11) $   (0.04) $    0.03  $    0.01
                                 =========  =========  =========  =========
Diluted                          $   (0.11) $   (0.04) $    0.02  $    0.00
                                 =========  =========  =========  =========

Weighted average common shares
 outstanding:
  Basic                             62,732     60,470     61,593     59,474
                                 =========  =========  =========  =========
  Diluted                           71,075     60,470     72,749     82,302
                                 =========  =========  =========  =========


Selected Balance Sheet Items:
(in thousands)

                                               September 30,  September 30,
                                                    2012           2011
                                               -------------  -------------

Cash and marketable securities                 $         281  $         518
Total assets                                   $       1,256  $       2,290
Stockholders' equity (deficit)                 $     (20,335) $     (23,259)

Add to Digg Bookmark with del.icio.us Add to Newsvine

Contact:
Russell Skibsted
Sr. Vice President and Chief Financial Officer
(949) 481-9825

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

@ThingsExpo Stories
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
In addition to all the benefits, IoT is also bringing new kind of customer experience challenges - cars that unlock themselves, thermostats turning houses into saunas and baby video monitors broadcasting over the internet. This list can only increase because while IoT services should be intuitive and simple to use, the delivery ecosystem is a myriad of potential problems as IoT explodes complexity. So finding a performance issue is like finding the proverbial needle in the haystack.
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
The WebRTC Summit New York, to be held June 6-8, 2017, at the Javits Center in New York City, NY, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 20th International Cloud Expo and @ThingsExpo. WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web ...
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Internet-of-Things discussions can end up either going down the consumer gadget rabbit hole or focused on the sort of data logging that industrial manufacturers have been doing forever. However, in fact, companies today are already using IoT data both to optimize their operational technology and to improve the experience of customer interactions in novel ways. In his session at @ThingsExpo, Gordon Haff, Red Hat Technology Evangelist, will share examples from a wide range of industries – includin...
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
"We build IoT infrastructure products - when you have to integrate different devices, different systems and cloud you have to build an application to do that but we eliminate the need to build an application. Our products can integrate any device, any system, any cloud regardless of protocol," explained Peter Jung, Chief Product Officer at Pulzze Systems, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at 20th Cloud Expo, Ed Featherston, director/senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
"Once customers get a year into their IoT deployments, they start to realize that they may have been shortsighted in the ways they built out their deployment and the key thing I see a lot of people looking at is - how can I take equipment data, pull it back in an IoT solution and show it in a dashboard," stated Dave McCarthy, Director of Products at Bsquare Corporation, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
IoT is rapidly changing the way enterprises are using data to improve business decision-making. In order to derive business value, organizations must unlock insights from the data gathered and then act on these. In their session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, and Peter Shashkin, Head of Development Department at EastBanc Technologies, discussed how one organization leveraged IoT, cloud technology and data analysis to improve customer experiences and effici...
Fact is, enterprises have significant legacy voice infrastructure that’s costly to replace with pure IP solutions. How can we bring this analog infrastructure into our shiny new cloud applications? There are proven methods to bind both legacy voice applications and traditional PSTN audio into cloud-based applications and services at a carrier scale. Some of the most successful implementations leverage WebRTC, WebSockets, SIP and other open source technologies. In his session at @ThingsExpo, Da...
"IoT is going to be a huge industry with a lot of value for end users, for industries, for consumers, for manufacturers. How can we use cloud to effectively manage IoT applications," stated Ian Khan, Innovation & Marketing Manager at Solgeniakhela, in this SYS-CON.tv interview at @ThingsExpo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
The cloud promises new levels of agility and cost-savings for Big Data, data warehousing and analytics. But it’s challenging to understand all the options – from IaaS and PaaS to newer services like HaaS (Hadoop as a Service) and BDaaS (Big Data as a Service). In her session at @BigDataExpo at @ThingsExpo, Hannah Smalltree, a director at Cazena, provided an educational overview of emerging “as-a-service” options for Big Data in the cloud. This is critical background for IT and data professionals...
@GonzalezCarmen has been ranked the Number One Influencer and @ThingsExpo has been named the Number One Brand in the “M2M 2016: Top 100 Influencers and Brands” by Onalytica. Onalytica analyzed tweets over the last 6 months mentioning the keywords M2M OR “Machine to Machine.” They then identified the top 100 most influential brands and individuals leading the discussion on Twitter.
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
In an era of historic innovation fueled by unprecedented access to data and technology, the low cost and risk of entering new markets has leveled the playing field for business. Today, any ambitious innovator can easily introduce a new application or product that can reinvent business models and transform the client experience. In their Day 2 Keynote at 19th Cloud Expo, Mercer Rowe, IBM Vice President of Strategic Alliances, and Raejeanne Skillern, Intel Vice President of Data Center Group and G...