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Added CLSN today: CLSN, a little DD:

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umiak Member Profile umiak Member Level 
Friday, July 20, 2012 12:52:21 PM
Re: None Post # of 19611 
Added CLSN today: CLSN, a little DD:

Coverage of CLSN...

https://roth2.bluematrix.com/docs/pdf/82b28b21-1772-4bc9-af1a-a116a3006623.pdf

From the CEO letter:

Quote:
Our work is of vital importance. The HEAT Study has been designated a Priority Study by the NIH; one of 8 among the hundred or so enrolling patients…and the only one evaluating a 1st line therapy. If we are right, we enter the market alone as a 1st choice for non-resectable disease. Is the world watching? ….You bet it is. The FDA among 10 other regulatory agencies around the world has given us every benefit possible for a speedy and successful trial because, as you know, the statistics are sobering.

Liver cancer is being described as a future epidemic in many populations and, as such, it is critical that the HEAT Study provide a rigorous data set to support ThermoDox's broad, global use. The incidence of primary liver cancer today is approximately 26,000 to 28,000 cases per year in the United States, approximately 40,000 cases per year in Europe and is rapidly growing worldwide at approximately 750,000 cases per year, due to the high prevalence of Hepatitis B and C in developing countries. By 2020, the World Health Organization estimates that primary liver cancer may become the #1 cancer worldwide, surpassing lung cancer.


Some stuff from Roth report tha catches my eye,

12 month price target, $10

ThermoDox--targeted chemo drug delivery system

Phase lll study has passed 7 reviews and a Data
Monitoring Committee (DMC) interim review

Orphan and Fast Track status

enrolling patients at centers in 11 countries
to help support regulatory filing in the U.S., E.U. and China.

Japanese partner Yakult

supply agreement with Hisun in China (for China distribution)

phase ll for advanced bc and bone cancer

key data catalysts expected in late 2012

targeted use of doxorubicin may decrease body toxicity and allow for longer term use, multible sites(?)

partnering potential


Upcoming Catalysts for Celsion
ThermoDox:
• 2Q12 – complete enrollment of 700 patients in the Phase III HEAT study of ThermoDox in primary liver cancer
• 2012 – initiation of the Phase II portion of the DIGNITY study of ThermoDox in recurrent chest wall breast cancer
• 2Q12 – Initiate a Phase II study of ThermoDox and HIFU in painful bone mets

2H12:
*another p3 independent review
*possible partner announcement
*p3 results


$24M cash on hand, company estimates last till Q32013 wow REALLY!!

Unexpected good news--6/7/12--http://ih.advfn.com/p.php?pid=nmona&article=52689591&symbol=CLSN

http://www.celsion.com/sec.cfm

OrbiMed is holding 6.69% of all outstanding shares in Celsion

Samuel D. Isaly is a founder and the Managing Partner of OrbiMed Advisors. Mr. Isaly is one of the world's most recognized healthcare fund managers and has been active in global healthcare investing and analysis since 1968 when he joined Chase Manhattan Bank in New York. During his career, Mr. Isaly has been a pharmaceutical analyst with Chase Manhattan Bank, Merrill Lynch, Legg Mason, SoGen Swiss International, Gramercy Associates and S.G. Warburg. Mr. Isaly launched OrbiMed's asset management business in 1989. Mr. Isaly has a B.A. in Economics from Princeton University and a M. Sc. (Econ.) from The London School of Economics


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