Dynavax Technologies Corp (DVAX)

[Pyckstocks]

$DVAX -Dynavax Technologies BIO dd


$DVAX Company Overview and Description



About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has been accepted for review by the FDA and a MAA has been accepted for review by the EMA. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

$DVAX has Heplisav review from the FDA -target date Feb 24, 2013.

About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines.

For more information visit http://www.dynavax.com

Info video about $DVAX Heplisav, released prior to the November 2012 FDA panel vote.

$DVAX Key Company Management
Dino Dina, M.D. – Chief Executive Officer and Director
Dr. Dina has been our President from May 1997 until July 2010, a member of our Board of Directors since May 1997 and our Chief Executive Officer since May 1998. From 1982 until he joined us in 1997, Dr. Dina was an employee of Chiron Corporation, a biopharmaceutical company. At Chiron, Dr. Dina held a series of positions with increasing responsibility. He ultimately served as president of Chiron Vaccines (formerly Biocine Company), which he directed from its inception in 1987. Under Dr. Dina's direction, Chiron Vaccines received the first-ever approval of an adjuvanted influenza vaccine in Italy, successfully completed development of the first genetically engineered pertussis vaccine, and conducted clinical trials for vaccines to prevent HIV, herpes simplex type II, cytomegalovirus, and hepatitis B infections. The virology group he directed was responsible for several key scientific findings, including the discovery, cloning, and sequencing of the hepatitis C virus, and the cloning and sequencing of the viral genomes for HIV and hepatitis A viruses. Prior to joining Chiron, Dr. Dina was employed at Albert Einstein College of Medicine in Bronx, New York, as an assistant professor of genetics from 1977 to 1982. He received his M.D. from the University of Genoa Medical School in Italy.

J. Tyler Martin, M.D. – President, Chief Medical Officer, and Director
Dr. Martin is the President, Chief Medical Officer and a member of our Board of Directors. Dr. Martin has nearly 20 years of drug development experience. Before joining Dynavax in 2009, Dr. Martin was President of Humabs LLC. Previously, Dr. Martin worked at Chiron as the Vice President, Development from 2004 until 2006 and the Director, Clinical Research from 1994 until 1997. In his 7 years at Chiron, Dr. Martin led the team responsible for the development of the novel vaccine adjuvant MF59, the first vaccine adjuvant licensed by regulatory agencies since alum, and approved as FLUAD influenza vaccine in Europe. He has also held senior development and research positions at Sangamo, Inc., Valentis, Inc. and SyStemix/GTI. Dr. Martin received a B.S. in Chemistry and an M.D. from the University of Nebraska. He completed his fellowship in pediatric infectious diseases and molecular microbiology at Washington University in St. Louis, Missouri.

Brant Biehn – Vice President
Mr. Biehn joined Dynavax in January 2010. Prior to joining Dynavax, Mr. Biehn held increasingly senior sales and marketing positions during his 21 year tenure at Merck. Since 2005, he has had responsibility for many adult vaccine products, including Merck's hepatitis A, hepatitis B and pneumococcal vaccines. Most recently, he served as International Market Lead for ZOSTAVAX®, a vaccine launched in the US in 2005 for the prevention of herpes zoster, or shingles as well as Merck's other adult vaccines. Prior to 2009, in his role as a global brand leader, he designed and managed marketing and sales programs, including distribution channels; targeted marketing to customer groups, payers, healthcare professionals, and consumers; and led country-specific marketing for ex-US markets. Over the past two years he worked with countries worldwide to supply pneumococcal polysaccharide vaccine to help prevent secondary bacterial infections that may result from pandemic flu infection. This program extended to both large public health programs as well as private health groups, with an emphasis on prevention of pandemic flu impacts. Earlier in his career Mr. Biehn created and led national sales organizations and directed multiple marketing efforts aimed at commercialization planning for new vaccine and human health products. Mr. Biehn earned a Bachelor of Science in Computer Science from the Memorial University of Newfoundland.

(ZOSTAVAX is a registered trademark of Merck & Co., Inc.)

Other beneficial management:
http://www.dynavax.com/management.html



$DVAX Contact Info
Dynavax Technologies
2929 Seventh Street, Suite 100
Berkeley, CA 94710
Phone: [phone]
Toll Free: +1.877.848.5100
Fax: [phone]
[e-mail]

Rhein Biotech GmbH
(Dynavax Europe)
Eichsfelder Strasse 11
D-40595 Düsseldorf
Phone: [phone]
Fax: [phone]
[e-mail]

Investor Relations
Phone: [phone]
[e-mail]



$DVAX Recent Developments
1) $DVAX is a clinical stage company with no products on the market yet.

2) $DVAX has Heplisav for FDA review on Feb 24, 2013. They also have two other items in their pipeline – (a) DV1179 for multiple autoimmune and inflammatory diseases including lupus, psoriasis, and rheumatoid arthritis partnered with GSK (b) AZD1419 for Asthma & and chronic obstructive pulmonary disorder partnered with AZN. While the pipeline items other than Heplisav have a large market potential, they are still early stage & should not be factored heavily in its valuation. Heplisav on the other hand, has a decent market potential o f$450-­$600 million in US & Europe (according to William Blair analysts) but this entirely depends on what label restrictions are placed on it.

3) $DVAX had an FDA Panel in Nov, 2012 which resulted in 13-1 positive for efficacy and 8-5 negative for efficacy. The stock fell immediately after the panel due to the safety concerns raised by the panel.

4) $DVAX’s PDUFA in Feb is still important despite panel’s negative votes because the panel’s safety concerns might not be enough to convince the FDA to issue a CRL and request new clinical trials. The company’s management believes that FDA will probably not request a large trial but might restrict the label & request post-marketing studies.

5) $DVAX has $148M as of Sep 2012 with a burn rate of about $15M per quarter. They have $34M Options and Warrants Outstanding. It looks like $DVAX has plenty of cash but additional study requests from FDA might lead to a dilution after the decision.

Competitors to watch during approval period. Some stocks follow the trend.

http://finance.yahoo.com/q/co?s=DVAX+Competitors

http://finance.yahoo.com/q/in?s=DVAX+Industry

http://finance.yahoo.com/q/sec?s=DVAX+SEC+Filings

http://finance.yahoo.com/q/it?s=DVAX+Insider+Transactions

http://finance.yahoo.com/q/mh?s=DVAX+Major+Holders

$DVAX Headlines
http://investors.dynavax.com/newsevents.cfm

$DVAX daily chart:




$DVAX Pipeline



Dynavax Technologies Corporation is a clinical-stage biopharmaceutical company that discovers and develops novel products to prevent and treat infectious and inflammatory diseases. Our lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine. A BLA for HEPLISAV has been accepted for review by the FDA , and an MAA has been accepted for review in Europe by the EMA.

clinical-stage product candidates include:
*Phase 3 HEPLISAV ™ Hepatitis B Vaccine
*Phase 1 TLR Inhibitor for Lupus
*Phase 1 Asthma Therapy

They have programs partnered with pharmaceutical companies, including AstraZeneca and GlaxoSmithKline.



Our European subsidiary Rhein Biotech manufactures hepatitis B surface antigen for HEPLISAV. With 20 years in business, Rhein Biotech also provides integrated product development services to enable its partners to bring products to market.

Publications
General | HEPLISAV | Influenza | Allergy/ Asthma | IRS / TLR Inhibitors | ISS / TLR | Cancer
http://www.dynavax.com/publications.html

Corporate presentation: http://files.shareholder.com/downloads/DVAX/2321892121x0x627273/05DC76D9-4B6A-43FF-9005-8A42639C02C2/Dynavax_corporate_presentation_Jan_2013.pdf



$DVAX Financial Reporting/Disclosure & Security Details

$DVAX follows under these guidelines on the Nasdaq market tier.

Investigate more @ http://www.otcmarkets.com/stock/DVAX/quote for more due diligence.

$DVAX Share Structure
Market Value1 $562,927,995 a/o Feb 15, 2013

Common stock per last 10Q (link below): $0.001 par value; 250,000 shares authorized; 178,270 and 154,626 shares issued and outstanding at September 30, 2012 and December 31, 2011, respectively

Shareholders
Shareholders of Record: 104 a/o Mar 06, 2009
Transfer Agent(s)
Computershare Trust Company, N.A.
250 Royall St.
Canton, MA 02021
[phone]
www.computershare.com/investor

Financial Reporting/Disclosure
Reporting Status: U.S. Reporting: SEC Filer
CIK: 0001029142
Fiscal Year End: 12/31
OTC Market Tier: Nasdaq

Profile Data
SIC - Industry Classification: 8731
Incorporated In: DE, USA
Year of Inc: incorporated in California in August 1996 under the name Double Helix Corporation, and changed their name to Dynavax Technologies Corporation in September 1996. reincorporated in Delaware in 2000
Security Notes
New Issue=2-19-04 6,000,000 shs at $7.50 by Bear, Stearns & Co., Inc. et al

Disclosure last 10Q reported Nov 2, 2012 period ending Sept 30, 2012
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=8893214

Before You Invest - Investigate! Always do your own due diligence
Investing in biotech business could be rewarding as well as philosophically satisfying. Biotech business is quite complex and highly risky for its intrinsic nature and complex variables of product approval.

A critical part of the due diligence: Please be aware, that upon completion of in-depth due diligence there is still a risk factor in all forms of investing.

Please note not all company websites are updated on a regular basis so you should use additional content sources to ensure accuracy.

Resources used in this post: otcmarket.com, www.bloomberg.com, www.finance.yahoo.com, $DVAX website