|By Marketwired .||
|August 15, 2014 07:00 AM EDT||
MISSION VIEJO, CA -- (Marketwired) -- 08/15/14 -- Aeolus Pharmaceuticals, Inc. (OTCQB: AOLS), a biotechnology company developing compounds to protect against radiological and chemical threats with significant funding from the US Government, announced today financial results for the three and nine months ended June 30, 2014.
The Company reported net income of approximately $1,576,000, or $0.01 per share for the three months ended June 30, 2014. This compares to a net loss of $786,000, or $0.01 per share, for the three months ended June 30, 2013.
For the nine months ended June 30, 2014, the Company reported net income of $445,000 or $0.00 per share. This compares to a net loss of $2,541,000 (including a non-cash adjustment for increases in valuation of warrants of $510,000) or $0.03 per share for the nine months ended June 30, 2013.
"During the quarter, we continued to make significant progress towards our goal of filing a pre-Emergency Use Authorization application for AEOL 10150 as a treatment for pulmonary effects of Acute Radiation Syndrome ('Lung-ARS') and we look forward to announcing a series of completed milestones in the development program over the next several months," stated John L. McManus, President and Chief Executive Officer. "We expect to file our IND for Lung-ARS before the end of August and to submit a Fast Track Application soon thereafter. Also, we expect to report preliminary results from our large rhesus macaque monkey study in Lung-ARS before the end of the current quarter, complete the remaining items in our manufacturing program to produce registration batches and present our annual report on progress to the Biomedical Advanced Research and Development Authority ('BARDA'). At the BARDA meeting we will request exercise of the next set of options under our development contract."
"Pending clearance of the Lung-ARS IND by the Food and Drug Administration ('FDA'), we plan to initiate a Phase 1 study in healthy normal volunteers funded by our BARDA contract. Thereafter, we will request Pre-IND meetings with the respiratory and oncology divisions of the FDA to finalize details for new INDs with those divisions to enable Phase 2 clinical studies in patients as we expand development of AEOL 10150 to other indications. These accomplishments, combined with the work already completed under our contract with BARDA should position us well to begin the process of a pre-Emergency Use Authorization filing."
Key Accomplishments During the Quarter:
- In June, three studies in two different strains of mice were initiated under the BARDA contract. The studies are designed to (1) determine the optimal duration of treatment with AEOL 10150 after radiation exposure, (2) expand beyond 24 hours the time at which treatment can be administered and, (3) explore the natural history of radiation damage to the lungs and AEOL 10150's effect beyond 180 days after exposure. Results from the duration and treatment window studies should be reported during the 1st half of calendar 2015. Natural history results are expected in the second half of 2015.
- Bridging studies comparing the new, improved formulation of AEOL 10150 to the old formulation were completed. The old formulation met FDA regulatory/toxicity guidelines for clinical administration in multiple human studies. The new regulatory compliant (GLP) studies demonstrated that the toxicity and pharmacokinetics of the formulations were comparable. This demonstration of comparability is expected to allow toxicology data generated with the old formulation to be used to support regulatory filings for the new formulation. These studies also showed that the new formulation is more stable at room temperature, less likely to cause irritation and has superior bioavailability in animals.
- Additional data was presented at the NIH CounterACT meeting in June providing further evidence of AEOL 10150's efficacy in improving survival in sulfur mustard exposure to the lungs and in providing protection against skin damage from nitrogen mustard exposure.
As of June 30, 2014, the Company had approximately $1,272,000 in cash and cash equivalents and 134,550,068 common shares outstanding. The Company had accounts receivable of $2,719,000 and accounts payable of $2,426,000 on June 30, 2014.
On May 5, 2014, the Company executed a Modification of Contract with BARDA. The purpose of the Modification was to (1) make available $1,777,882 in reimbursement to the Company for actual indirect costs incurred under the first three years of its contract with BARDA, (2) establish an increased provisional indirect billing rate for FY2014 and, (3) cap future adjustments to the indirect billing rate for the remaining contract period of performance. The Company received payment of the $1,777,882 on May 15, 2014. The effect of the Modification was (a) to increase the cash balance of the Company and (b) to increase the billing rate for indirect costs under the contract.
Results of Operations for the Three Months Ended June 30, 2014
Revenue for the three months ended June 30, 2014 was approximately $4,983,000, versus revenue of $844,000 for the three months ended June 30, 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, the receipt of $1,777,882 in reimbursement under the Modification of Contract and revenue recognition under accounting rules.
Research and development expenses increased to approximately $2,829,000 for the three months ended June 30, 2014, from approximately $727,000 for the three months ended June 30, 2013. The increase in 2014 expenses reflects both the initiation of program items under the BARDA contract (including manufacturing improvements and non-human primate studies) and expense recognition under accounting rules.
General and administrative expenses were approximately $577,000 for the three months ended June 30, 2014 compared to approximately $903,000 for the three months ended June 30, 2013. The lower expense was due to savings in employee salaries and benefits and reduced legal expenses.
Results of Operations for the Nine Months Ended June 30, 2014
Revenue for the nine months ended June 30, 2014 was approximately $7,214,000, which compares to revenue of $3,045,000 for the nine months ended June 30, 2013. The revenue is from the contract with BARDA announced on February 11, 2011. Higher revenue in 2014 reflects the initiation of program items, the receipt of $1,777,882 in reimbursement under the Modification of Contract and revenue recognition under accounting rules.
Research and development expenses increased to approximately $4,709,000 for the nine months ended June 30, 2014, from approximately $2,514,000 for the nine months ended June 30, 2013. The increase in 2014 expenses reflects both the initiation of program items under the BARDA contract (including manufacturing improvements and non-human primate studies) and expense recognition under accounting rules.
General and administrative expenses were approximately $2,059,000 for the nine months ended June 30, 2014 compared to approximately $2,562,000 for the nine months ended June 30, 2013. The lower expense was due to savings in employee salaries and benefits and legal expenses.
Aeolus has filed today with the SEC its Quarterly Report on Form 10-Q for the quarter ended June 30, 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.
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) June 30, September 30, 2014 2013 ------------- ------------- ASSETS Current assets: Cash and cash equivalents $ 1,272 $ 869 Accounts receivable 2,719 370 Deferred subcontractor cost 794 656 Prepaid and other current assets 70 39 ------------- ------------- Total current assets 4,855 1,935 Investment in CPEC LLC 32 32 ------------- ------------- Total assets $ 4,887 $ 1,966 ============= ============= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued expenses $ 2,426 $ 579 Deferred revenue 825 682 ------------- ------------- Total current liabilities 3,251 1,261 ------------- ------------- Total liabilities 3,251 1,261 Commitments and Contingencies (Note F) Stockholders' equity : Preferred stock, $.01 par value per share, 10,000,000 shares authorized: Series B nonredeemable convertible preferred stock, 1,600,000 and 1,600,000 shares authorized as of June 30, 2014 and September 30, 2013, respectively; 526,080 and 526,080 shares issued and outstanding as of June 30, 2014 and September 30, 2013, respectively 5 5 Common stock, $.01 par value per share, 200,000,000 shares authorized; 134,550,068 and 134,550,068 shares issued and outstanding as of June 30, 2014 and September 30, 2013, respectively 1,346 1,346 Additional paid-in capital 183,762 183,276 Accumulated deficit (183,477) (183,922) ------------- ------------- Total stockholders' equity 1,636 705 ------------- ------------- Total liabilities and stockholders' equity $ 4,887 $ 1,966 ============= =============
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
AEOLUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except per share data) Three Months Ended Nine Months Ended June 30, June 30, ------------------- ------------------- 2014 2013 2014 2013 --------- --------- --------- --------- Revenue: Contract revenue $ 4,983 $ 844 $ 7,214 $ 3,045 Costs and expenses: Research and development 2,829 727 4,709 2,514 General and administrative 577 903 2,059 2,562 --------- --------- --------- --------- Total costs and expenses 3,406 1,630 6,769 5,076 --------- --------- --------- --------- Income (Loss) from operations 1,576 (786) 445 (2,031) Non-cash financing charges and change in fair value of warrants (Note B) -- -- -- (510) --------- --------- --------- --------- Net income (loss) $ 1,576 $ (786) $ 445 $ (2,541) ========= ========= ========= ========= Net income (loss) per weighted share attributable to common stockholders: Basic (Note D) $ 0.01 $ (0.01) $ 0.00 $ (0.03) ========= ========= ========= ========= Diluted (Note D) $ 0.01 $ (0.01) $ 0.00 $ (0.03) ========= ========= ========= ========= Weighted average common shares outstanding: Basic 134,550 134,550 134,550 97,120 ========= ========= ========= ========= Diluted 136,861 134,550 136,829 97,120 ========= ========= ========= =========
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
AEOLUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (In thousands) Nine Months Ended June 30, ---------------------- 2014 2013 ---------- ---------- Cash flows used in operating activities: Net income (loss) $ 445 $ (2,541) Adjustments to reconcile net income (loss) to net cash used in operating activities: Stock-based compensation 485 584 Change in fair value of warrants -- 510 Change in assets and liabilities: Accounts receivable (2,349) 539 Deferred subcontractor cost (138) (935) Prepaid and other assets (31) 10 Accounts payable and accrued expenses 1,846 (246) Deferred revenue 143 972 ---------- ---------- Net cash provided by (used in) operating activities 403 (1,107) ---------- ---------- Cash flows provided by financing activities: Proceeds from issuance of common stock and warrants -- 3,616 Costs related to the issuance of common stock and warrants -- (58) ---------- ---------- Net cash provided by financing activities -- 3,558 ---------- ---------- Net increase (decrease) in cash and cash equivalents 403 2,451 Cash and cash equivalents at beginning of period 869 281 ---------- ---------- Cash and cash equivalents at end of period $ 1,272 $ 2,732 ========== ==========
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
President and Chief Executive Officer
Aeolus Pharmaceuticals, Inc.
"Operations is sort of the maturation of cloud utilization and the move to the cloud," explained Steve Anderson, Product Manager for BMC’s Cloud Lifecycle Management, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Jul. 23, 2016 05:00 PM EDT Reads: 1,775
The IoT has the potential to create a renaissance of manufacturing in the US and elsewhere. In his session at 18th Cloud Expo, Florent Solt, CTO and chief architect of Netvibes, discussed how the expected exponential increase in the amount of data that will be processed, transported, stored, and accessed means there will be a huge demand for smart technologies to deliver it. Florent Solt is the CTO and chief architect of Netvibes. Prior to joining Netvibes in 2007, he co-founded Rift Technologi...
Jul. 23, 2016 05:00 PM EDT Reads: 923
Enterprise networks are complex. Moreover, they were designed and deployed to meet a specific set of business requirements at a specific point in time. But, the adoption of cloud services, new business applications and intensifying security policies, among other factors, require IT organizations to continuously deploy configuration changes. Therefore, enterprises are looking for better ways to automate the management of their networks while still leveraging existing capabilities, optimizing perf...
Jul. 23, 2016 04:45 PM EDT Reads: 885
Security, data privacy, reliability and regulatory compliance are critical factors when evaluating whether to move business applications from in-house client hosted environments to a cloud platform. In her session at 18th Cloud Expo, Vandana Viswanathan, Associate Director at Cognizant, In this session, will provide an orientation to the five stages required to implement a cloud hosted solution validation strategy.
Jul. 23, 2016 04:30 PM EDT Reads: 654
Unless your company can spend a lot of money on new technology, re-engineering your environment and hiring a comprehensive cybersecurity team, you will most likely move to the cloud or seek external service partnerships. In his session at 18th Cloud Expo, Darren Guccione, CEO of Keeper Security, revealed what you need to know when it comes to encryption in the cloud.
Jul. 23, 2016 04:00 PM EDT Reads: 2,290
The cloud competition for database hosts is fierce. How do you evaluate a cloud provider for your database platform? In his session at 18th Cloud Expo, Chris Presley, a Solutions Architect at Pythian, gave users a checklist of considerations when choosing a provider. Chris Presley is a Solutions Architect at Pythian. He loves order – making him a premier Microsoft SQL Server expert. Not only has he programmed and administered SQL Server, but he has also shared his expertise and passion with b...
Jul. 23, 2016 04:00 PM EDT Reads: 1,801
We're entering the post-smartphone era, where wearable gadgets from watches and fitness bands to glasses and health aids will power the next technological revolution. With mass adoption of wearable devices comes a new data ecosystem that must be protected. Wearables open new pathways that facilitate the tracking, sharing and storing of consumers’ personal health, location and daily activity data. Consumers have some idea of the data these devices capture, but most don’t realize how revealing and...
Jul. 23, 2016 04:00 PM EDT Reads: 1,963
What are the successful IoT innovations from emerging markets? What are the unique challenges and opportunities from these markets? How did the constraints in connectivity among others lead to groundbreaking insights? In her session at @ThingsExpo, Carmen Feliciano, a Principal at AMDG, will answer all these questions and share how you can apply IoT best practices and frameworks from the emerging markets to your own business.
Jul. 23, 2016 03:45 PM EDT Reads: 1,488
Basho Technologies has announced the latest release of Basho Riak TS, version 1.3. Riak TS is an enterprise-grade NoSQL database optimized for Internet of Things (IoT). The open source version enables developers to download the software for free and use it in production as well as make contributions to the code and develop applications around Riak TS. Enhancements to Riak TS make it quick, easy and cost-effective to spin up an instance to test new ideas and build IoT applications. In addition to...
Jul. 23, 2016 03:30 PM EDT Reads: 1,828
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
Jul. 23, 2016 03:15 PM EDT Reads: 768
Extracting business value from Internet of Things (IoT) data doesn’t happen overnight. There are several requirements that must be satisfied, including IoT device enablement, data analysis, real-time detection of complex events and automated orchestration of actions. Unfortunately, too many companies fall short in achieving their business goals by implementing incomplete solutions or not focusing on tangible use cases. In his general session at @ThingsExpo, Dave McCarthy, Director of Products...
Jul. 23, 2016 03:00 PM EDT Reads: 1,643
Many private cloud projects were built to deliver self-service access to development and test resources. While those clouds delivered faster access to resources, they lacked visibility, control and security needed for production deployments. In their session at 18th Cloud Expo, Steve Anderson, Product Manager at BMC Software, and Rick Lefort, Principal Technical Marketing Consultant at BMC Software, discussed how a cloud designed for production operations not only helps accelerate developer in...
Jul. 23, 2016 03:00 PM EDT Reads: 1,176
Ask someone to architect an Internet of Things (IoT) solution and you are guaranteed to see a reference to the cloud. This would lead you to believe that IoT requires the cloud to exist. However, there are many IoT use cases where the cloud is not feasible or desirable. In his session at @ThingsExpo, Dave McCarthy, Director of Products at Bsquare Corporation, will discuss the strategies that exist to extend intelligence directly to IoT devices and sensors, freeing them from the constraints of ...
Jul. 23, 2016 02:30 PM EDT Reads: 1,696
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, discussed the importance of WebRTC and how it enables companies to focus...
Jul. 23, 2016 02:15 PM EDT Reads: 617
Venafi has extended the power of its platform in an easy-to-use utility for DevOps teams available for immediate download. Now DevOps teams can eliminate the hassle of acquiring and installing TLS keys and certificates. Instead, customers can focus on speeding up continuous development and deployment, while security teams have complete visibility and can keep the DevOps environment secure and compliant to protect customer data. Extending the Venafi Trust Protection Platform requires only a singl...
Jul. 23, 2016 02:00 PM EDT Reads: 999