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Daily Dose Newsroom is a Daily Dose of Wall Street research and news in the Healthcare, Biotech, and Biomedical sectors.

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Entries in Biodefence (15)

Wednesday
Jun062012

Binghamton University S3IP Center and Applied DNA Sciences Partner on DNA Authenticity Technologies for Microelectronics (APDN)

Applied DNA Sciences, Inc. (OTCBB:APDN) is a provider of botanical-DNA based security and authentication solutions that can help protect products, brands and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. SigNature® DNA and smartDNA®, our principal anti-counterfeiting and product authentication solutions that essentially cannot be copied, provide a forensic chain of evidence and can be used to prosecute perpetrators.

Applied DNA, together with The New York State Center of Excellence in Small Scale Systems Integration and Packaging at Binghamton University (S3IP), New York, has announced "the signing of a Memorandum of Understanding calling for collaboration on microelectronics research and commercialization, and other projects. The two organizations aim to embark on various projects, including further advancements in Applied DNA Sciences' forensic authentication and security technologies."

The partnership utilizes the skilled staff and advanced facilities at S3IP, in combination with the technology, business experience and product lines of APDN. This new relationship comes as the defense industry searches for new ways to battle the incoming flood of counterfeit electronics that have plagued both consumer and the military markets. Applied DNA and S3IP will work "to commercialize the resulting applications, with the potential to impact the estimated $3.1 billion annual flow of semiconductors to the U.S. military(1) and a global commercial market in semiconductors valued well in excess of $300 billion."

United States Senator Kirsten Gillibrand (D-NY) welcomed the new partnership, commenting,

"New York is poised to lead in the high-tech economy of the future. When we partner our world class universities and research laboratories with cutting-edge businesses like S3IP in Binghamton and Applied DNA Sciences on Long Island, we can spark new innovation with the power to protect our defense technology, keep our country safe, and attract new businesses and new jobs to help grow our economy."

The partners will develop a joint research program to develop "new ways to embed and authenticate DNA on various substrates. The advances are aimed at extending the company's botanically derived DNA technology to new verticals and to future needs. According to the Memorandum of Understanding signed by The Research Foundation for the State University of New York, whose office is located at Binghamton University Office of Sponsored Programs, and by APDN, the partners will aim to scale up new methods for SigNature DNA incorporation into and onto a variety of materials."

Additionally, the program may involve "testing of marked packaging of microchips in coordination with APDN partners, and explore advances in rapid reading solutions for screening chips in varying scenarios." 

Bahgat Sammakia, interim vice president for research, and director of S3IP at Binghamton University, commented,

"S3IP works in partnership with government, academia and industry to enable new electronics applications for energy, healthcare, telecommunications and consumer applications, and defense industries. We are excited about this partnership with Applied DNA Sciences, which will enable new research opportunities for our faculty, staff and students. This program is just one example of the benefits of working in collaboration with industry, the results of which will bridge our expertise in biotechnology and information technology to enable new opportunities for ensuring the security of our nation's electronic systems."

Said Dr. James A. Hayward, President and CEO of Applied DNA Sciences,

"Our collaboration with Binghamton University extends our commitments to collaborative research with NYS universities, including our current work with Stony Brook University, and the College of Nanotechnology Science and Engineering at the University of Albany. Combined with Long Island's heritage in DNA science and in the defense industry, we could not be in a better strategic location to extend our biotechnologies for microelectronics."

Read the full article at adnas.com

Thursday
May172012

Soligenix Reports First Quarter 2012 Financial Results and Highlights Recent Accomplishments (SNGX)

Soligenix, Inc. (SNGX.OB) is a development stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. Soligenix's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid that has been initially developed for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. Soligenix is also developing oral BDP for the prevention/treatment of other gastrointestinal disorders characterized by severe inflammation, including acute radiation enteritis (SGX201), which is the subject of a recently completed National Cancer Institute (NCI)-supported Phase 1/2 clinical trial and pediatric Crohn's disease (SGX203).

The Company has announced its financial results for the quarter ending March 31, 2012. 

For the quarter ending March 31, 2012, Soligenix's revenues were $647,418, as compared to $808,005 for the first quarter of 2011. The decrease in revenues was "related to a reduction in reimbursable costs from the Company's Orphan Drug Grant covering a portion of its confirmatory Phase 3 clinical trial of orBec® in the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD)."

For the quarter ending March 31, 2012, Soligenix's net loss was $1,438,755, or $(0.13) per share, as compared to $1,720,411, or $(0.16) per share for the quarter ending March 31, 2011. This represents a decreased loss of $281,656, which is primarily attributable to reduced spending due to "the stoppage of the Phase 3 clinical trial of orBec® in acute GI GVHD.  This study was stopped in September 2011 and the Company has continued to incur minor costs associated with the close out of the clinical sites, data collection and analysis."

Research and development expenses for the quarter ending March 31, 2012 were $876,794 as compared to $1,372,804 for the quarter ending March 31, 2011. This decrease is primarily attributable to reduced spending in connection with the Phase 3 clinical trial of orBec®. General and administrative expenses for the quarter ending March 31, 2012 were $655,043, compared to $604,010 for the quarter ending March 31, 2011.

As of March 31, 2012, the Company's cash position was approximately $5,320,000 with working capital of approximately $4,440,000.   

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated,

"In the first quarter of 2012 we saw meaningful progress in our Vaccine/BioDefense business segment particularly with our novel vaccine thermostabilization technology, ThermoVax™. We also continue to progress with development efforts of our oral BDP program for pediatric Crohn's disease and plan to initiate a Phase 2A clinical trial this year. We remain committed to enhancing our product development pipeline through internal efforts and external strategic alliances. We look forward to reporting on further progress this year regarding our Vaccine/BioDefense programs."
Wednesday
Apr252012

Soligenix ($SNGX): Announces further progress with ThermoVax 

Soligenix announced that progress has been based on additional characterization of the stability of prototype vaccines that have been kept at elevated temperatures in excess of three months.

  • Prior results have indicated that the company's aluminum-adjuvanted ricin toxin vaccine, known as RiVax, retained effectiveness and potency while stored at 40 degrees Celsius for one month when combined with the ThermoVax technology.
  • Confirmatory results have now extended these initial observations to more than three months when the vaccine is kept at 40 degrees Celsius. In contrast, liquid RiVax vaccine when stored at 40 degrees Celsius rapidly degraded and no longer maintained its effectiveness.

Tuesday
Apr102012

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.


"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
Monday
Apr092012

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.

Friday
Apr062012

Soligenix Inc. releases corporate presentation ($SNGX)

Soligenix Inc. (SNGX) is a development stage biopharmaceutical company committed to developing products to treat life-threatening side effects of cancer treatments and serious gastrointestional diseases, and vaccines for certain bioterrorism agents.  Soligenix has two areas of focus:

  1. Therapeutics segment dedicated to the development of products for orphan diseases and areas of unmet medical need such as pediatric Crohn’s disease, acute radiation enteritis, and Graft-versus-Host disease (GVHD), and
  2. A vaccine/biodefense segment to develop vaccines and therapeutics for military and civilian applications.

The Company has released an updated corporate presentation, current as of April 2012. The presentation includes information about the company’s value proposition, senior management team, indepedent board directors, pipeline, market potential, past and future milestones, and more.

Below is the value proposition: 

Corporate

  • Diversified portfolio: BioTherapeutics and Vaccines/BioDefense
  • Multiple programs in rare disease and areas of unmet medical need
  • Significant NIH/FDA grant support for most programs
  • Experienced management and board of directors
  • End of first quarter 2012 cash approximately $6 million
  • Clean capital structure with no debt or preferred stock outstanding
  • Largest shareholder Sigma-Tau; approximately 26% ownership
BioTherapeutics 

  • Oral BDP application for inflammatory gastrointestinal (GI) indications – acute radiation enteritis and pediatric Crohn’s Disease; markets in excess of $500 million worldwide 
  • 35% royalty generating partnership with Sigma-Tau on orBec®/oral BDP for North America and Europe

Vaccines/BioDefense

  • ThermoVaxTM heat stabilization technology capable of eliminating cold chain distribution and storage concerns
  • Grant funded and revenue generating – $9.4 million NIH grant award
  • 3 novel BioDefense development candidates
  • RiVaxTM – a world leader in ricin toxin vaccine research 
  • SGX202 (oral BDP) – compelling pre-clinical results in GI acute radiation syndrome (ARS)
  • SGX204 – novel hyperimmunogenic anthrax vaccine from Harvard

View the full presentation below.  

Tuesday
Apr032012

Conference Call 4/4/12: Cleveland Biolabs ($CBLI): Update on BARDA development funding process 

Cleveland BioLabs ($CBLI) announces that the company received a response from the Biomedical Advanced Research and Development Authority of the Department of Health and Human Services (BARDA) indicating that BARDA has declined to invite the company to submit a full proposal at this time for continued development funding of CBLB502 as a radiation countermeasure.

Notwithstanding this notification, the company plans to continue the development of CBLI502 as a radiation countermeasure without interruption. Management states..." We will keep pursuing additional funding from various governmental agencies, including BARDA and our existing Department of Defense funding partners at the Chemical Biological Medical Systems and Defense Threat Reduction Agency."

There will be a conference call tomorrow Wednesday April 4, 2012 at 9:00 am 877-643-7158 (US) or 914-495-8565 (International).

Friday
Mar232012

Biotech Stock Mailbag: Xoma's Big Backers, FDA Approvals Contest - $XOMA

XOMA Corporation (NASDAQ: XOMA) is a biotechnology company focused on the discover and development of monoclonal antibody-based therapeutics.  
 
XOMA’s world-class monoclonal antibody technologies have contributed to the development of marketed biologics with a total of more than $1 billion in annual sales and for which XOMA received substantial royalties. The company also has a strong track record of product discovery and development collaborations with pharmaceutical and biotechnology companies and the U.S. government, and has licensed certain of its fundamental technologies to numerous pharma and biotech companies. 
 
At TheStreet.com, senior columnist Adam Feuerstein wrote an article in answer to a reader's question: "Why is Xoma up 50% for the month?" 
 
Feuerstein explained that the stock rose because "Baker Bros., a well-respected and closely followed health-care hedge fund, bought half the Xoma deal" of $40 million financing that was announced on March 6. 
 

He continued,

"The question you're probably asking now is, "Wait a second -- Xoma? What the hell can Baker Bros. see in Xoma?" [I wondered the same thing.] Xoma is apparently getting a new lease on life, thanks to a top-to-bottom restructuring -- a new CEO and chief medical officer, cost cutting and a new business model. Xoma is still developing the same lead drug XOMA 052 (given a new name, gevokizumab) but money-wasting efforts in diabetes and cardiovascular indications have been shelved in favor of clinical trials for Behcets uveitis and non-infectious uveitis -- both diseases of the eye.
 
A phase III study of gevokizumab is expected to start this summer with data likely available by the end of 2013."
 
Daily Dose: We spoke with an analyst who covered Xoma for years. The analysts shared with us, that the indication "Behcets uveitus" has promising data.  Xoma has managed to stay alive since the dawn of biotech and sooner or later, this stock should work.

Read the full article at TheStreet.com.