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Daily Dose Newsletter

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 cndo (7)

Monday
Jun252012

Coronado Biosciences Added to Russell 3000(R) Index

Coronado Biosciences, Inc., (CNDO), a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, announced today the Company has been added to the Russell Global, Russell 3000(R) and Russell Microcap(R) Indexes following the reconstitution of the Russell's U.S. and global equity indexes.

"We are excited to be included in the Russell 3000(R) Index," said Dr. Bobby W. Sandage, Jr., Coronado's President and CEO. "We believe that our addition to the Index will increase the visibility of our Company to a broader range of potential investors."

Annual reconstitution of Russell's U.S. indexes captures the 4,000 largest U.S. stocks as of the end of May, ranking them by total market capitalization to create the Russell 3000(R) Index and Russell Microcap Index. Membership in the Russell 3000, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000(R) Index or small-cap Russell 2000(R) Index as well as the appropriate growth and value style indexes. The Russell 3000 also serves as the U.S. component to the Russell Global Index, which Russell launched in 2007. Russell determines membership for its equity indexes primarily by objective, market-capitalization rankings and style attributes.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for both passive and active investment strategies. In the institutional marketplace, an industry-leading $3.9 trillion in assets currently are benchmarked to them. Russell calculates more than 80,000 benchmarks daily covering approximately 98 percent of the investable market globally, 83 countries and more than 10,000 securities. These investment tools originated from Russell's multi-manager investment business in the early 1980s when the company saw the need for a more objective, market-driven set of benchmarks in order to evaluate outside investment managers.

About Coronado Biosciences

Coronado Biosciences is engaged in the development of novel immunotherapy biologic agents. The company's two principal pharmaceutical product candidates in clinical development are: TSO (Trichuris suis ova or CNDO-201), a biologic for the treatment of autoimmune diseases, such as Crohn's disease, ulcerative colitis and multiple sclerosis; and CNDO-109, a biologic that activates natural killer (NK) cells, for the treatment of acute myeloid leukemia (AML) and solid tumors.

Forward-Looking Statements

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the company's product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated risks relating to the results of research and development activities, uncertainties relating to preclinical and clinical testing, financing and strategic agreements and relationships, the early stage of products under development, our need for substantial additional funds, government regulation, patent and intellectual property matters; our dependence on third party suppliers and competition, as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contact:
Investor Relations
Lucy Lu, MD, Executive Vice President
& Chief Financial Officer
Coronado Biosciences, Inc.
781-238-6619; ir@coronadobio.com
Marcy Nanus, Vice President
The Trout Group, LLC.
646-378-2927; mnanus@troutgroup.com
Media Relations
Dennis S. Dobson Jr., CEO
Dobson Media Group
203-258-0159; dobsonpr@erols.com
Tuesday
Apr242012

Coronado Biosciences receives recommendation to continue Falk phase 2 trial of TSO in Crohn's disease

Coronado Biosciences, Inc. (Nasdaq: CNDO), a biopharmaceutical company focused on the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced that it received from Dr. Falk Pharma GmbH (Falk), its development partner, a recommendation from the independent data monitoring committee that conducted an interim analysis (blinded to Falk) of clinical data from the initial 120 patients to continue Falk's Phase 2 clinical trial in Europe evaluating Trichuris suisova (TSO) in Crohn's disease. The committee noted no safety concerns and a positive efficacy trend in its recommendation that the study continue. See the full release @

http://www.proactivenewsroom.com/Blog/bid/85980/Coronado-Biosciences-Announces-Independent-Data-Monitoring-Committee-Recommendation-to-Continue-Falk-Phase-2-Trial-of-TSO-in-Crohn-s-Disease

Daily Dose Updates:

  • CNDO received from Dr. Falk Pharma GmbH (Falk), its development partner, a recommendation from the independent data monitoring committee that conducted an interim analysis (blinded to Falk) of clinical data from the initial 120 patients to continue Falk's Phase 2 clinical trial in Europe evaluating Trichuris suis ova (TSO) in Crohn's disease.
  • The committee noted no safety concerns and a positive efficacy trend in its recommendation that the study continue.
  • Falk has advised they are adopting the committee's recommendations to increase the sample size and to conduct a subsequent interim analysis at the time the trial reaches approximately 250 patients.
  • The Falk trial, entitled Double-blind, randomised, placebo-controlled, multi-centre phase II study to evaluate the efficacy and safety of three different dosages of oral Trichuris suis ova (TSO) suspension in active Crohn's disease, is being conducted in Europe and was initially expected to enroll approximately 212 patients and to evaluate three different dosages of TSO versus placebo.
Tuesday
Feb142012

Prima BioMed files for NASDAQ listing (ASX: PRR)

 

Just a quick heads up that Australian biotech company Prima BioMed (ASX: PRR) has filed for a NASDAQ listing of American Depositary Receipts (ADR). Once the listing is complete the company will have a dual listings of its securities on both the Australian Securities Exchange (ASX) and NASDAQ. Every one ADR will represent 30 common shares, so Prima at $0.17 cents would trade at $5.10 and a market cap of >$160 mln.

Prima’s proposed NASDAQ listing will be a Level II ADR compliance listing, and is being managed by Bank of New York Mellon and US broking houses Deutsche Bank AG, Noble Financial and Aegis. Prima did say that they are currently unable to say precisely when the shares will actually list and trade but we expect it will be soon.

Here the big question: Is this a blessing or a Curse ?

Prima is listing on the NASDAQ for better exposure and most importantly access to U.S. capital markets. The company is now beginning a Phase III trial in ovarian cancer using a dendritic cell based vaccine (in the U.S., Progenitor Cell Therapy (NeoStem-NBS) is doing the manufacturing, recall that PCT did the clinical work for Dendreon's Provenge and is also working for Coronado (CNDO) and Immunocellular (IMUC). If anyone can make sure that the "manufacturing goes off with-out a hitch” its PCT-NBS. 

So the next big question, is does it work ? Ovarian is a very tough indication and the life expectancy of Ovarian cancer varies a great deal. Prima's Phase II data was not double blinded cross-over so the results are not definitive. No way to say what the results of the current global PIII trial will be yet. We do know Prima will likely need to raise capital at some point ahead (thus the U.S. listing).

Perhaps the most important event that investors will watch will be not Prima at all, but Merck KG who is running the StimuVax trial which like Prima's product (C-Vac) targets the MUC-1 antigen (over-expressed in ovarian cancer).

If StimuVax works, Prima could rock, if not, it could flop as it validates one way or another the MUC-1 antigen as a target.

Let’s watch Prima and see how the company does as they work to build a U.S. institutional presence and present their data to the scrutiny of US investors.

Monday
Jan092012

ProActive Capital Resources Group Announces Client Participation at San Francisco Healthcare Conferences

JP Morgan's 30th Annual Healthcare Conference 

5th Annual OneMedForum San Francisco 2012

Biotech Showcase 2012 in San Francisco

New York, NY, January 9, 2012 – ProActive Capital Resources Group, a strategic corporate communications, investor relations and social media firm today announced that several of its clients will be presenting at three prestigious investor conferences in San Francisco next week. The following companies will be presenting their corporate presentations at JP Morgan's 30th Annual Healthcare Conference, the 5th Annual OneMedForum San Francisco 2012, and the Biotech Showcase 2012 in San Francisco.

“We are proud to have several of our clients presenting at these quality industry conferences as we continue to grow our healthcare practice at ProActive Capital,” stated Jeff Ramson, CEO of ProActive Capital Resources Group. “These healthcare conferences provide the visibility and help build awareness as our clients continue to execute on their growth initiatives.”

To schedule a one on one meeting with any of the companies please contact us at the number below.

Coronado Biosciences, Inc. (Nasdaq:CNDO), will present at the Biotech Showcase 2012 Conference on Wednesday, January 11, 2012 at 4:30 PM PT.

Ventrus BioSciences, Inc. (Nasdaq:VTUS) will be attending the conferences and is available for one on one meetings.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) will be presenting at JP Morgan's 30th Annual Healthcare Conference on Thursday, January 12, 2012 at 10:00 a.m. PT.

WaferGen Biosystems, Inc. (OTCBB:WGBS.OB) - The company is scheduled to present at OneMedForum on Tuesday, January 10, 2012 beginning at 10:00 a.m. PT.

Tonix Pharmaceuticals Holding Corp. (OTCBB:TNXP.OB), will be presenting at the Biotech Showcase 2012 on Monday, January 9, 2012 at 10:00 a.m. PT, as well as on Tuesday, January 10, 2012 at 10:15 a.m. PT at the OneMedForum Conference.

AtheroNova, (OTCQB: AHRO.OB) will be attending the conferences and is available for one on one meetings.

Fibrocell Science, Inc. (OTCBB:FCSC.OB), will be presenting at the 5th Annual OneMedForum on Wednesday, January 11, 2012 at 10:00 a.m. PT.

Cerecor Inc. (a privately held company) will present at the Biotech Showcase 2012 on Monday, January 9th at 10:00 AM PST. 

NeoStem, Inc. (NYSE Amex: NBS) will be presenting at Biotech Showcase 2012 on January 10, 2012 at 10:30 a.m. PT.

CytoSorbents Corporation (OTC.BB: CTSO.OB), will present at the OneMedForum 2012 on Wednesday, January 11, 2012 at 11:15a.m. PT.

For more information about each of the conferences, go to:

www.onemedplace.com/forum/

http://www.ebdgroup.com/bts/index.php

About ProActive Capital Resources Group, LLC

ProActive Capital Resources Group, LLC (“PACRG”) (www.proactivecrg.com) is dedicated to the discovery and creation of value in the small-cap marketplace. PACRG provides turnkey solutions that combine traditional investor relations services with the latest Internet, mobile and social media communications. The Company’s integrated digital media and global distribution platform www.ProActiveNewsroom.com connects innovative, emerging-growth companies to the investment community using a variety of user-friendly and interactive formats.

Investor Relations Contact:

Jeff Ramson

Proactive Capital Resources Group, LLC.

212-792-4294

jramson@proactivecrg.com

Saturday
Jan072012

The TurnAround in Dendrion ? DNDN Presents at JP Morgan in SFO

Last week Dendreon NASDAQ: DNDN reported stronger than expected sales for Provenge sales at $82 Million generally above "street" consensus expectations. The company has a strong cash balance (approx. $600M) to fund the Provenge launch through to profitability. The stock rallied sharply starting the week at $8 and closing north of $12. This sets the stage for continued expansion for Dendrion and is welcome news for earlier stage cancer immune based therapies in development.

This week the JP Morgan Healthcare Conference begins in San Fransico, Monday through Thursday. Healthcare companies from all over the world converge for a week in meetings with sell side analysts, bankers and institutional portfolio managers.

We have been highlighting the Alliance for Regenerative Medicine (ARM) efforts as an industry group to highlight the progress that cell based companies have made over the past decade. To this end, ARM has organized a two day mini-conference (we have previously posted the schedule). What's special about the ARM event is that the companies will all present in a panels style format.

Industry leaders like Dendrion (presenting on a panel Wed) will be alongside other earlier stage companies in their market niche such as Immunocellular (IMUC), Coronado (CNDO), PrimaBioMed (PRR.AX) as well as other players in the space. We believe this will be a great venue for investors to learn not only about where Dendrion may be going as a stock, but what's next in the cancer-immunotherapy space.

We will be present throughout the day and blogging on the various panels as we go through the motions of comparing and contrasting the various approaches of the companies. For example we are keenly focused to listen to the cardiology panel where industry leader MesoBlast (MSB) will present alongside NeoStem (Amorcyte-NBS), Athersys (ATHX) and Cytori (CYTX).  Baxter (BAX) will not be present for the panel but investors should take note of their progress (P3 trial in cardiac ischemia).

We believe the next major breakthroughs on the regen side will likely be found in the cardiology space.

Tuesday
Dec202011

Coronado: CNDO - Makes the NASDAQ

Coronado began trading on the NASDAQ as CNDO, and was off in its first day of trading, $6 (down $0.50). Coronado is a fascinating story in immunology on two fronts, on the cell therapy side with an NK cell that rebuilds patients immunity and the other product CNDO-201 is a "whip worm" product. Normally we would consider this a parasite but in this case, the ova from the porcine helminth Trichuris suis may work symbiotically in man, to help re-balance out of balance "auto-immune" system. A phase IIb trial is scheduled to begin in 1Q-2012 to treat Crohn's disease patients but the implications here could reach as far as Multiple Sclerosis (MS).

Please see our write-ups here on Daily Dose and also on the ProActive Coronado page. We know that National Securities and their army of 750 retail brokers helped raise the initial capital, (as they did for Ventrus -VTUS) last year to bring this company public. As of September, the company has $26.7 million in cash. Coronado starts trading with a strong retail following as management now works to create an institutional following.

Monday
Dec122011

Cell Therapy - Is there value for stock market investors?

The cell therapy space has been hit hard over the past year triggered by a perfect storm of events from the macro-economic environment:

  • Biotechnology has come under pressure, where investors fear not only dilution but extinction; and
  • Companies in the Small-Cap Biotech space often operate with a years worth of cash, and this has made investors nervious.

We have been down this road in the past, can anybody say Y2K?

Dendreon's (NASDAQ: DNDN) rise became the rallying cry for investors so its subsequent plunge became the proof for the bears that cell therapy just doesn't work. Both examples are in our opinion false. Provenge, like so many biotech products before it, is the first in a new therapeutic category. We lived through the monoclonal antibodies in the 90's, and then the HIV market in Y2K. Most recently the success of the nucleosides (Pharmasset) is now destined to be acquired by Gilead (GILD). We hope our followers saw the run up in Inhibitex (INHX) that resulted.

What's the connection? A pattern has emerged, and Provenge is not just a cell therapy but the first of a cell based approach to immunology/cancer. The follow-on products will be better. Take a look at the work that PrimaBioMed (ASX: PRR) is doing or even better, Coronado (OTCBB: CNDO) (which we have been following for some time).

What we want to begin discussing today is cell therapy on the regenerative medicine side of the equation. Oncology has always had tough hurdles but on the regenerative side the unmet medical need is often just as great, in fact, greater in some places. 

No one yet has been able to explain Mesoblast (MSB-Australia) to us but Cephalon and now Teva are in partnership and the stock has a market cap approaching $2 billion. This is an allogenic (other peoples cells) model, which pharma likes. It is the so called pills in a bottle model. Peer companies include Pluristem (PSTI) and Athersys (ATHX), at much lower valuations ($100 million or lower). On the autlogous side no one seems to be paying any attention to NeoStem (AMEX: NBS). This company acquired Progenitor Cell Therapy the contract manufacturing company that worked on Provenge and today is working with many of the cell therapy companies we are following.

Can an autlogous model work?  Baxter thinks so, and has been highlighting their autlogous cells for cardiac ischemia. Interesting because the Baxter product is very similar to the NeoStem product - both are CD34+ cells with some differences. NeoStem is begining their Phase 2 trial for a cell therapy that promises to stabilze failing hearts after a heart attack.

We recently attended the Stem Cell Therapy on the Mesa conference, and we were "blown away" with the number of products in clinical trials. We saw companies from all over the world - some had revenues with approved products, and others had great data and proof of concept with thereapies that can work for everything from cardiovascular disease to healing damaged muscles and tendons.

Going Forward: We will be actively following the "Cell Therapy Space" now. That means we will be watching the developments on two fronts:

  • Oncology/Immunology side, and
  • Regenerative Medicine side.

We will be commenting on the trials, the news developments in the space, the competitive landscape, talking with managment, and posting our articles on where we believe the ground breaking science, product profiles, and catalysts lie that can trigger the next paradigm shift in the space.

Remember, Lipitor is going to leave a big hole in Pfizer's pipleine as it goes generic. Pharma and Biotech have to act. Early signs abound that cell therapies are no longer a case of if, but when, and the answer to that is tied to clinical trials, which represent a highly defined process.