|By Marketwired .||
|January 2, 2013 10:59 AM EST||
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.
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)
Sr. Vice President and Chief Financial Officer
Companies can harness IoT and predictive analytics to sustain business continuity; predict and manage site performance during emergencies; minimize expensive reactive maintenance; and forecast equipment and maintenance budgets and expenditures. Providing cost-effective, uninterrupted service is challenging, particularly for organizations with geographically dispersed operations.
May. 27, 2016 02:00 PM EDT Reads: 1,973
SYS-CON Events announced today that BMC Software has been named "Siver Sponsor" of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. BMC is a global leader in innovative software solutions that help businesses transform into digital enterprises for the ultimate competitive advantage. BMC Digital Enterprise Management is a set of innovative IT solutions designed to make digital business fast, seamless, and optimized from mainframe to mo...
May. 27, 2016 01:45 PM EDT Reads: 2,141
SoftLayer operates a global cloud infrastructure platform built for Internet scale. With a global footprint of data centers and network points of presence, SoftLayer provides infrastructure as a service to leading-edge customers ranging from Web startups to global enterprises. SoftLayer's modular architecture, full-featured API, and sophisticated automation provide unparalleled performance and control. Its flexible unified platform seamlessly spans physical and virtual devices linked via a world...
May. 27, 2016 01:15 PM EDT Reads: 2,163
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discuss how businesses can gain an edge over competitors by empowering consumers to take control through IoT. We'll cite examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He'll also highlight how IoT can revitalize and restore outdated business models, making them profitable...
May. 27, 2016 12:30 PM EDT Reads: 2,812
IoT generates lots of temporal data. But how do you unlock its value? How do you coordinate the diverse moving parts that must come together when developing your IoT product? What are the key challenges addressed by Data as a Service? How does cloud computing underlie and connect the notions of Digital and DevOps What is the impact of the API economy? What is the business imperative for Cognitive Computing? Get all these questions and hundreds more like them answered at the 18th Cloud Expo...
May. 27, 2016 12:00 PM EDT Reads: 2,219
SYS-CON Events announced today that EastBanc Technologies will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. EastBanc Technologies has been working at the frontier of technology since 1999. Today, the firm provides full-lifecycle software development delivering flexible technology solutions that seamlessly integrate with existing systems – whether on premise or cloud. EastBanc Technologies partners with p...
May. 27, 2016 10:30 AM EDT Reads: 2,216
SYS-CON Events announced today Object Management Group® has been named “Media Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
May. 27, 2016 10:00 AM EDT Reads: 2,391
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
May. 27, 2016 10:00 AM EDT Reads: 3,103
In his session at 18th Cloud Expo, Bruce Swann, Senior Product Marketing Manager at Adobe, will discuss how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects). Bruce Swann has more than 15 years of experience working with digital marketing disciplines like web analytics, social med...
May. 27, 2016 10:00 AM EDT Reads: 1,297
SYS-CON Events announced today that Tintri Inc., a leading producer of VM-aware storage (VAS) for virtualization and cloud environments, will exhibit at the 18th International CloudExpo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
May. 27, 2016 10:00 AM EDT Reads: 2,330
SYS-CON Events announced today that ContentMX, the marketing technology and services company with a singular mission to increase engagement and drive more conversations for enterprise, channel and SMB technology marketers, has been named “Sponsor & Exhibitor Lounge Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York. “CloudExpo is a great opportunity to start a conversation with new prospects, but what happens after the...
May. 27, 2016 09:45 AM EDT Reads: 1,077
The IoTs will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm and share the must-have mindsets for removing complexity from the development proc...
May. 27, 2016 09:00 AM EDT Reads: 1,889
What a difference a year makes. Organizations aren’t just talking about IoT possibilities, it is now baked into their core business strategy. With IoT, billions of devices generating data from different companies on different networks around the globe need to interact. From efficiency to better customer insights to completely new business models, IoT will turn traditional business models upside down. In the new customer-centric age, the key to success is delivering critical services and apps wit...
May. 27, 2016 08:45 AM EDT Reads: 1,126
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
May. 27, 2016 08:00 AM EDT Reads: 2,370
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, will provide 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 ...
May. 27, 2016 07:45 AM EDT Reads: 1,929
As cloud and storage projections continue to rise, the number of organizations moving to the cloud is escalating and it is clear cloud storage is here to stay. However, is it secure? Data is the lifeblood for government entities, countries, cloud service providers and enterprises alike and losing or exposing that data can have disastrous results. There are new concepts for data storage on the horizon that will deliver secure solutions for storing and moving sensitive data around the world. ...
May. 27, 2016 07:00 AM EDT Reads: 1,280
SYS-CON Events announced today that MobiDev will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. MobiDev is a software company that develops and delivers turn-key mobile apps, websites, web services, and complex software systems for startups and enterprises. Since 2009 it has grown from a small group of passionate engineers and business managers to a full-scale mobile software company with over 200 develope...
May. 27, 2016 06:15 AM EDT Reads: 2,548
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, will discuss the importance of WebRTC and how it enables companies to fo...
May. 27, 2016 05:15 AM EDT Reads: 2,496
SYS-CON Events announced today that MangoApps will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. MangoApps provides modern company intranets and team collaboration software, allowing workers to stay connected and productive from anywhere in the world and from any device. For more information, please visit https://www.mangoapps.com/.
May. 27, 2016 05:00 AM EDT Reads: 736
SYS-CON Events announced today TechTarget has been named “Media Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. TechTarget is the Web’s leading destination for serious technology buyers researching and making enterprise technology decisions. Its extensive global networ...
May. 27, 2016 04:45 AM EDT Reads: 3,143