BARDA Delivers Notice of Intent to Exercise Additional Contract Options With Aeolus Worth $9.1 Million (AOLS)

Aeolus Pharmaceuticals, (AOLS) Inc. is a biotechnology company leveraging significant government funding to develop a platform of novel compounds in oncology and biodefense. The Company 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 studies made by US Government agencies in AEOL 10150 to efficiently develop the compound for use in oncology. 

The Company announced that "it has received from the Biomedical Advanced Research and Development Authority (BARDA) a Notice of Intent to Exercise options valued at $9.1 million. The bulk of the options are for the period of performance beginning April 1, 2012 and ending March 31, 2013, and include funding for murine and NHP Efficacy studies in Lung Acute Radiation Syndrome (Lung-ARS), GMP manufacturing, and project management costs." Because of this, The Company expects revenue for the 2012 fiscal year to be in the range of $9 to 11 million, which is an increase from it's fiscal year 2011 revenue of $4.8 million.

Chief Executive Officer and President of Aeolus Pharmaceuticals, Inc. John L. McManus commented,

"BARDA's notice of intent to exercise additional options reflects the hard work and success of our development team and research partners, and our combined success during the first year of the Lung-ARS development contract. During the base period, we delivered valuable animal models for Lung-ARS and made important progress in the manufacturing of AEOL 10150. The options that BARDA intends to exercise will fund the key animal efficacy studies necessary for the design of our ultimate pivotal studies, as well as important chemistry, manufacturing and controls projects, and will keep our development plan on schedule. We remain grateful to BARDA for the financial support and program input that we receive."

The Company will be hosting a Conference Call on Tuesday, April 10, 2012 @ 11am Pacific/2pm Eastern.

Domestic: 877-837-3910      

International: 973-796-5077      

Webcast and replays will be available at www.aeoluspharma.com. 

Read the full release at Yahoo Finance. 

CDC Report: Sepsis Hospitalizations Rates Double Across Last Decade, Driven by Elderly; $CTSO

CytoSorbents Corporation (OTCBB: CTSO) is a critical-care focused therapeutic device company using blood purification to treat life-threatening illnesses. These are common, major conditions seen in the intensive care unit (ICU), such as sepsis and infection, severe trauma, burns, lung injury, and pancreatitis, that afflicts millions of people each year yet lacks effective therapies, leading to a mortality rate that often exceeds 30%. Failure of multiple organs, such as the lungs, heart, kidneys and liver, is the leading causes of death from these conditions, for which very little can be done today. Hospital acquired infections are another leading cause of death in the ICU. CytoSorbents is developing novel and advanced blood purification therapies designed to actively prevent, mitigate, or reverse the development of organ failure and infection, thereby potentially reducing illness severity and helping patients to heal and recover faster. Ultimately the goal is to improve patient outcome and save healthcare costs. Nearly 1% of the US gross domestic product (GDP), or approximately $90 billion, is spent on critical care annually in the US, and billions of dollars are lost by hospitals each year due to a lack of effective therapies. 

Recently, the U.S. Centers of Disease Control and Prevention (CDC) published a report on the epidemiology of sepsis in the US after examining hospital admission data from 2000 to 2008 from the National Hospital Discharge Survey. According to the researchers, “the number of hospitalizations for sepsis more than doubled between 2000 and 2008, resulting in much longer, costlier hospital stays and more fatal outcomes”. The jump in sepsis rates were attributable to several factors, including the aging population, a rise in invasive procedures, and the increased use of catheters. Read more report highlights here. 

But in particular, the elderly were driving the statistics. Patients 65 and older:

1. Have other conditions that put them at high risk of infection such as diabetes, cancer, and implanted medical devices like artificial hips and knees.
2. Are driving the incidence of sepsis hospitalizations, recently accounting for two-thirds of all patients hospitalized with sepsis in the U.S.
3. Have a 13-fold relative risk of death compared to patients younger than age 65.
4. Are the ones dying of sepsis, predominantly from multi-organ failure and hospital acquired infections, rather than the original infection itself.

CEO of CytoSorbents Dr. Phillip Chan stated,

"Unfortunately, most of us know someone who has died from sepsis and other complications of serious infections like pneumonia, urinary tract infections, abdominal infections, and influenza. Although sepsis kills thousands of babies, children, teens, and young adults each year, it is unquestionable that older patients, particularly those 65 and older, have the highest risk of both developing a serious infection and dying from it. Despite antibiotics, approximately one-third of patients in the U.S. and Europe still die each year from severe sepsis each year, making it a top ten leading cause of death in the U.S. and elsewhere. And to make things worse, there are no available therapies in the U.S. or the European Union that are approved to specifically treat sepsis."

Dr. Chan continued,

"CytoSorbents has developed a blood purification therapy called CytoSorb™ that works with antibiotics, and targets the underlying fundamental reasons why people die of sepsis, which are multi-organ failure and additional infections. An inadvertent overproduction of cytokines, or ‘cytokine storm’, by the immune system is a key driver of the severe inflammation that then leads to cell death and organ failure, and a paralysis of the immune system. By reducing ‘cytokine storm’, CytoSorb™ aims to reduce or mitigate organ failure and additional infecitons, thereby helping patients to get better, faster. Based on data from our European Sepsis Trial, CytoSorb™ appears to have a unique protective effect on patients 65 and older, preventing death to 14 days. If we can extend this treatment benefit in future studies, CytoSorb™ has the potential to revolutionize not only sepsis treatment in this patient population, but other life-threatening illnesses where cytokine storm plays a deadly role."

CDC Sepsis Brief 2011

View more documents from CytoSorbents

DD Education: Which Cell Therapy companies present the best value? Part 2

We developed an analysis using public filings and annualizing the most recent quarters as of 12/31/11. As such, the accuracy is subjective to our proprietary algorithm, and this list is not mean to be all comprehensive.

We conclude that ex leaders Dendreon and MesoBlast make the space very inexpensive. The sample below represents just over $500 million in market cap for eight of the selected public companies (ex DNDN and MSB). These companies have 3 - PIII trials, 5 PII trials and several P1 trials (based on these crude metrics).

We conclude that is worth investors time to understand among these companies in terms of what they are doing and the associated probabilities of success of their trials. Recent data peaks from the Cardiology space suggests that Baxter (BAX) and their CD34 cell type may be very viable. NeoStem has a very similar approach. The retrenchment in MesoBlast shares since that company presented data at AHA in November is of concern. Cytori, Aastrom, Athersys all have active programs in cardiology while Athersys lead program is partnered with Pfizer for Ulcerative Colitis and Aastrom is entering a Phase 3 trial in CLI.

By price ($), Osiris, MesoBlast, and Dendreon are the highest $ priced stocks:

But that starts to change as we migrate to market cap:

And if we eliminate Mesoblast and Dendreon we get a better picture of the rest of the field:

And that picture changes as we adjust for debt and cash: (enterprise value). In all fairness here, we know that NeoStem with $20-$30 million in value from their China generic company, could be the cheapest name and others are / will raise capital but ex China, Athersys is the “cheapest name”.

Looking at R&D spending: IMUC, Prima and NeoStem are among the most efficient but in fairness one must adjust for the fact that Aastrom is embarking on a pivotal trial versus Prima just starting their P3 and NeoStem their P2.

Revenues: Here we have excluded NeoStem’s $65 million from China which means PCT (Cell Therapy CMO) is running at close to $10 million in annual revenues (currently).

Aeolus ($AOLS): BioDefense - Acute Radiation Syndrome. There is Hope !

Aeolus ($AOLS) received a BARDA notice of intent to exercise options is triggered by Aeolus' successful execution of the first year of its contract. (This is positive news for the company).

The bulk of the options are for the period of performance beginning April 1, 2012 and ending March 31, 2013, and include funding for murine and NHP Efficacy studies in Lung Acute Radiation Syndrome (Lung-ARS), GMP manufacturing, and project management costs.

The company expects revenue to increase to $9 to $11M for fiscal year 2012, as a result of the project.

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Rodman & Renshaw Annual Global Investment Conference September 9-11, 2012 in NYC

Rodman & Renshaw will have its 14th annual healthcare conference from September 9-11, 2012 at the Waldorf Astoria in New York, NY.

The Annual Global Investment Conference has the following areas of interest: 

• Autoimmune Diseases
• Cardiovascular Diseases
• CNS Disorders
• Drug Delivery
• Gene Therapy
• Infectious Diseases
• Medical Devices
• Molecular Diagnostics
• Oncology
• Orphan Diseases 
• Stem Cells
• Vaccines 

WHO SHOULD ATTEND: 

• Institutional Investors
• Venture Capital Firms 
• Sophisticated Private Investors
• Industry Executives 
• Business Development Executives
• Private Equity Firms   

CONFERENCE FORMAT:

• Corporate Presentations
• Investor One-on-One Meetings
• Daily Networking Opportunities over Breakfast, Lunch and Cocktails

For more information, see www.rodmanandrenshaw.com.  

Which Cell Therapy companies present the best value?

In the wake of a robust season of financings, and low valuations we revisit the basic questions in the cell therapy space, updating our tables for year end reported financials. Our numbers are forward looking and subjective to our proprietary algorithm, and this list is not mean to be all comprehensive.

Dendreon and MesoBlast remain the market leaders, but the best values by far are in the micro-cap space with names like Aastrom and PluriStem funded with strong balance sheets.

The sample below represents just over $875 million in market cap for eight of the selected public companies (ex DNDN and MSB). These companies have 3 - PIII trials, 5 PII trials and several P1 trials (based on these crude metrics).

We conclude that is worth investors time to understand among these companies in terms of what they are doing and the associated probabilities of success of their trials.

By price ($), Osiris, MesoBlast, and Dendreon are the highest $ priced stocks: 

By Price ($), Osiris , MesoBlast and Dendreon are the highest $ price:

But that starts to change as we migrate to market cap:

And if we eliminate Mesoblast and Dendreon we get a better picture of the rest of the field:

And that picture changes as we adjust for debt and cash (enterprise value):

Looking at R&D spend gives us an idea of who is spending what on clinical programs:

Barron's on AVI BioPharma: "Bad Timing for a Promising Stock" $AVII

Shares of AVI BioPharma dropped after results of a key clinical trial disappointed Wall Street. A partnership with a big drug firm could revive the stock.

From Barron's:

"The ink had barely dried on our latest issue when AVI BioPharma (ticker: AVII), the subject of a bullish article ("Waiting and Hoping," April 2), released data early Monday morning from a key clinical trial for its drug to treat Duchenne muscular dystrophy. The news was good, but not good enough to meet elevated expectations on Wall Street.

AVI's lead drug, called eteplirsen, is doing better than the stock, which could reward patient investors.

See the full story @ Barron's.

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The Weekly Dose - April 6, 2012

The Weekly Dose - April 6, 2012

Weekly Commentary - Financings seem to be the topic of the last few weeks.  BioWorld published a great article, "Spring has Sprung: Venture funding in BioTech is up. From that article: "Based on BioWorld's data, the first three months of 2012 saw U.S. biotech venture rounds bringing in a rousing $391 million – a 34 percent increase compared to the same period last year. 

In the cell therapy space we have just survived several raises. Aastrom, Athersys and NeoStem (just to name a few) all raised capital. Aastrom deal was creative with a long term debt note. The good news is they should be financed through PIII results now. Typically we do see stocks rise post financings as fundamentally the enterprise value is even more attractive.  Does dilution matter ? It’s a great question but the answer in the world of biotech is not so simple. These companies are working to completely change the unmet medical need around usually novel indications. In the case of Aastom its CLI, Athersys is Ulcerative Colitis (&others) and NeoStem is cardiovascular disease (preservation of heart function). So in this regard if these companies demonstrate "proof of principal" in their P2 (NBS, ATHX) or P3 (ASTM), the dilution from these raises becomes "irrelevant.

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