RiverBabe's Baby Biotechs

[tiedyed1]

Curis, Inc. (CRIS)?

Hi River.

I was wondering if you had any opinion on CRIS?
The company has some collaboration with Genentech and was recently added to the NASDAQ Biotech Index.

Thank you for starting this thread. I think it is tremendous contribution to the board.

Keep On Keepin' On;
Adam
tiedyed1

[riverbabe]

Cris

Hi River.

I was wondering if you had any opinion on CRIS?
The company has some collaboration with Genentech and was recently added to the NASDAQ Biotech Index.

Thank you for starting this thread. I think it is tremendous contribution to the board.

Keep On Keepin' On;
Adam
tiedyed1

Hi Adam:

Curis is giving a poster presentation at ASCO (American Society of Clinical Oncology), June 8, 2010, on GDC-0449 (partnered with Roche/Genentech) a drug for colorectal cancer. The presentation will report the results of a "safety analysis" from a Phase II clinical trial.

This is a poster presentation they gave highlighting preclinical data related to CUR-906 (a different one in the pipeline) at AACR (American Association for Cancer Research) on 4/10/2010: http://curis.com/AACR_2010_Poster%20CUR-906.pdf

A poster presentation is just that: picture it pinned or taped up on a bulletin board with a researcher standing or sitting on a chair beside it, ready to answer questions from people stopping by. Poster presentations are all presented this way in a huge exhibit hall, hundreds and hundreds of them all at once. The hall is very crowded with people wandering around looking at posters such as these. Believe me, I have been there, done that many times, both presenting and looking and answering and asking questions.

It is an honor to have an abstract accepted for presentation at ASCO. It is even a greater honor to make a live, oral presentation to researchers (like DelCath is doing).

Curis has a great pipeline, but none of their drugs has progessed beyond Phase II. Reminder: Only with successful Phase III clinical trials can the data be presented in a New Drug Application (NDA) for approval by the FDA. Phases I & II are tests of "does it work in a few patients?" is it safe? at what doses does it produce results? at what doses does it produce side effects? what are the side effects? Phase III clinical studies are double-blind studies involving a large number of patients. That's where you get the proof in the pudding!

They have good partnerships and are profitable at this time due to licensing some of their technology.

Bottom line, this is a drug "development" company. Not yet producing or selling product. Presuming the Phase II studies tell them something, progressing to Phase III will take time. They have to find enough willing patients, produce enough of the drug in various dosages, get statistically significant results, satisfy the FDA that their data is enough to justify an approval. (or a non-approval, asking for more data, etc. etc. etc.)

You are looking at several years at least for the most promising candidate to complete Phase III, and 6 months to a year after that to try for FDA approval. Depends what your personal time frame is. If they present favorable "safety data" at ASCO there could be a bounce in the stock. But it might not be sustainable in this market. This is a long haul. If you have spare change to throw at it and forget about it for a few years, this might be a good place to get in. Although, the data might not be accepted as favorable at ASCO. Coin toss, with faith, if you think it will be great.

Good luck!

[riverbabe]

Dcth

Okay, I gotta mention DelCath Systems (DCTH)one more time! It was UP today, 0.56 cents. The only one of my stocks that is in the green! By 3.49%!!! This stock is the kind I am talking about when I say, WOW Phase III clinical data, NDA application to be submitted to FDA in 3Q/4Q, action on application expected by middle of 2011. And they are doing an oral presentation at ASCO on June 5th, 2010 that should give the stock a boost.

There are no guarantees about the stock. All I can say is, this is what you look for in a baby biotech. It's like another Dendreon. Revolutionary technology that works. I'm hanging on for now!

Delcath Reconfirms Presentation During American Society of Clinical Oncology 2010 Annual Meeting in Chicago
Wednesday, 19 May 2010 20:51 Late-breaking abstract will be released during the Annual Meeting
NEW YORK, May 19 -- Delcath Systems, Inc. (Nasdaq: DCTH), a development stage, specialty pharmaceutical and medical device company focused on oncology, reconfirmed today that the American Society of Clinical Oncology (ASCO) has accepted an oral presentation of Delcath's Phase III Trial Data comparing percutaneous hepatic perfusion with melphalan (PHP-mel) to the best alternative care for patients with hepatic metastases from ocular or cutaneous melanoma (now there's a tough one!) for ASCO's 2010 Annual Meeting, to be held June 4-8, 2010 at McCormick Place in Chicago.

James F. Pingpank, MD, FACS, Associate Professor of Surgery at the University of Pittsburgh School of Medicine and a lead Principal Investigator of the Phase III trial, will present the abstract on June 5 at 3:30 PM, during the Melanoma/Skin Cancer – Oral Abstract Session.

The abstract concerning Delcath's Phase III Clinical Trial is a late–breaking abstract. Per ASCO policy, all late-breaking abstracts will be publicly released on site at the Annual Meeting. According to ASCO, this process ensures that pivotal research accepted into ASCO's Annual Meeting is presented and discussed in a peer-review setting. These abstracts will also be made publicly available online for the first time over the duration of the Annual Meeting, June 4-8, 2010.

About Delcath Systems, Inc.

Delcath Systems, Inc. is a development stage, specialty pharmaceutical and medical device company focused on oncology. Delcath's proprietary system for chemosaturation is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic liver cancers. Delcath recently concluded a Phase III metastatic melanoma study and the Company is currently conducting a multi-arm Phase II trial to treat other liver cancers. For more information, please visit the Company's website at www.delcath.com.

[tiedyed1]

Thanks for the feedback on CRIS. Those poster presentations must be very tedious and I guess part of the game. I know some people trading it and now I can better understand why. It will sit in the trading range it has been in for years forward. I was and still am curious why it was added to the Nasdaq Biotech Index with so much in question looking ahead; but i guess that is just the prominent nature of most biotechs?

I appreciate you sharing your criteria and am rooting for your DelCath to hit a payday more sooner than later!

Thanks again; Adam
tiedyed1

[riverbabe]

Live feed from ASCO re. DCTH & others

This link is to a live feed blog today by Adam Feuerstein from TheStreet.com at the meeting of the American Society of Clinical Oncology in Chicago.

http://www.thestreet.com/_yahoo/story/10773728/1/asco-live-blog-saturday.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA

Delcath (DCTH) presents at 3:30 PM. Up 39 cents in the AH market to 15.04. He is also reporting on other presentations, so if your favorite baby biotech or big pharma is presenting today, pay attention. Good luck to all. This is one of the "biggie" meetings.

Willing to answer any questions you have, if I can. River

[Peter Hansen]

Pbth

River, Bio Tech Stock analyst extraordinaire, do ya have any info on PBTH. It appears to have a great chart?

[riverbabe]

Curis, for Tiedyed1

Thanks for the feedback on CRIS. Those poster presentations must be very tedious and I guess part of the game. I know some people trading it and now I can better understand why. It will sit in the trading range it has been in for years forward. I was and still am curious why it was added to the Nasdaq Biotech Index with so much in question looking ahead; but i guess that is just the prominent nature of most biotechs?

I appreciate you sharing your criteria and am rooting for your DelCath to hit a payday more sooner than later!

Thanks again; Adam
tiedyed1

This is the latest on the live blog (see below) on CRIS! Sounds goods!
adam feuerstein: last presentation on GDC-0449 from Curis. (hey! it's a small cap bio, so pay attention!!!)
Saturday June 5, 2010 10:50 adam feuerstein

10:51 adam feuerstein: first report on activity of GDC-0449 in patients with medulloblastoma (the most common brain tumor in children)
Saturday June 5, 2010 10:51 adam feuerstein

10:51 adam feuerstein: about 400 kids in the U.S. are diagnosed iwth medulloblastoma each year
Saturday June 5, 2010 10:51 adam feuerstein

10:53 adam feuerstein: Small, phase I study show encouraging activity. 12/13 children with recurrent or drug-resistant medulloblastoma tolerated drug well without significant side effects. one patients remained on drug for more than a year without disease progression - very atypical in this disease.
Saturday June 5, 2010 10:53 adam feuerstein

10:55 adam feuerstein: Will be interesting to see if Curis sees some action monday based on these data. Recall, Curis is partnered with Roche/Genentech. GDC-0449 is also being studied in other tumor types.

[riverbabe]

Pbth

River, Bio Tech Stock analyst extraordinaire, do ya have any info on PBTH. It appears to have a great chart?

Pete, I'll get back to you tomorrow on this.

[riverbabe]

Sorry to keep harping on this, but thot the following was interesting:

[Comment From T.K. Horeis T.K. Horeis : ]
So what have been the most interesting or surprising results you've seen thus far? Saturday June 5, 2010 1:42 T.K. Horeis


1:44 adam feuerstein: Nothing surprising yet. And nothing dramatically great, either. Honestly, i think most of the institutional investors here are more worried about the state of the market than they are about cancer-focused biotech stocks. At dinner last night with some hedge fund friends, they're freaking out a bit about the market.


Saturday June 5, 2010 1:44 adam feuerstein

1:49 adam feuerstein: I said this yesterday on twitter but i'll repeat it here, i'm struck by how much Big Pharma is dominating the conversation at this year's ASCO meeting. Nearly all of the big data presentations highlighted by ASCO are coming out of Big Pharma. This shift in power from biotech to BIg Pharma is not new, but it's very pronounced this year.

This doesn't mean the ASCO meeting is a dud for biotech, just that the impact of this meeting for biotech, particularly small call biotech, might be muted.
Saturday June 5, 2010 1:49 adam feuerstein

1:51 adam feuerstein: But i know you guys understand (or you should) that the "ASCO trade" is already over. Selling in ASCO-related stocks has already started and don't be surprised to see it continue Monday. (The dismal direction of the overall market isn't helping matters, for sure.)

The silver lining, of course, is that selling does create buying opportunities.


Saturday June 5, 2010 1:51 adam feuerstein

2:05 adam feuerstein: I'm getting pitched on all sides by companies with GBM (brain tumor) drugs... weird. this was a clinical backwater for years, now, it's hot. -- Celldex, ImmunoCellular, Exelixis, Roche/Genentech. I just heard another pitch from a privately held Israeli company, Novocure, with a GBM device that apparently posted positive phase III data.
Saturday June 5, 2010 2:05 adam feuerstein

AND

4:04 adam feuerstein: I have my seat for the DCTH presentation. I had to walk to Indiana to get here.
Saturday June 5, 2010 4:04 adam feuerstein

4:06 adam feuerstein: I ventured outside on my way over here, passing a gaggle of cancer docs smoking. i see this at every ASCO, still makes me laugh.
Saturday June 5, 2010 4:06 adam feuerstein

[riverbabe]

Pbth

River, Bio Tech Stock analyst extraordinaire, do ya have any info on PBTH. It appears to have a great chart?

This Israeli company Prolor is pretty impressive. The CTP technology makes scientific sense (it was developed at Washington University, St. Louis), there is a great potential market for the eventual products, Merck has taken one of Prolor's licensed products through Phase III clinical trials and has received marketing approval from the EC (European) for marketing in Europe. They (Prolor) have other products in the pipeline, although none currently in Phase III; but the list of uses for this CTP technology (adding a very small protein to the end of a therapeutic protein to extend its half-life in the body) seems endless. They are currently seeking other partners.

The company is covered currently by two analysts. They completed a stock offering of $24.4M in March 2010. And, the Chairman of the Board is the Vice-Chairman of the Board of Governors of AMEX!!! (jeepers)

They are presenting at the 2010 Jeffries Global Life Sciences conference on June 8, 2010 at 11:30 AM. http://finance.yahoo.com/news/PROLOR....html?x=0&.v=1

They rang the opening bell at NYSE/AMEX on June 3rd. http://finance.yahoo.com/news/Spence....html?x=0&.v=1

Okay, I can stop now with the FA attempt. Let's go to the TA:

The hype associated with the presenting and ringing above must be giving the stock a boost.

Pete, I'm not going to post the charts here because you can read them as well as me. The stock gapped up (daily) on June 1st and continued up June 2nd on above average volume, probably in anticipation of the bell ringing. Then it hit the resistance (6.32) that first became apparent on 5/12 (6.34). Double top. Wonder if the buyers of the March stock offering decided it was time to take profits. Since then, more profit-taking on above average down volume.

That was a lot of stock they offered in March. It may take a while for this profit-taking to work itself through. Also, on the weekly 6.34 looks like the end of the 5 up Elliott wave, and may be going into an abc correction.
Can only speculate if the pps will get a boost from the Tuesday June 8th presentation. If it does, I would look for more profit-taking.

This is a great company Pete with a whole lot of great connections, money, and a business plan. Any announcement about a potential new partnership, etc. would surely give it a boost. But, in the meantime IMHO, it needs to work thru the resistance. If it breaks it decisively on big volume, with an announcement impetus, I'd get in. Good luck, and thanks for bringing it here.

[Peter Hansen]

River Thanx

This Israeli company Prolor is pretty impressive. The CTP technology makes scientific sense (it was developed at Washington University, St. Louis), there is a great potential market for the eventual products, Merck has taken one of Prolor's licensed products through Phase III clinical trials and has received marketing approval from the EC (European) for marketing in Europe. They (Prolor) have other products in the pipeline, although none currently in Phase III; but the list of uses for this CTP technology (adding a very small protein to the end of a therapeutic protein to extend its half-life in the body) seems endless. They are currently seeking other partners.

The company is covered currently by two analysts. They completed a stock offering of $24.4M in March 2010. And, the Chairman of the Board is the Vice-Chairman of the Board of Governors of AMEX!!! (jeepers)

They are presenting at the 2010 Jeffries Global Life Sciences conference on June 8, 2010 at 11:30 AM. http://finance.yahoo.com/news/PROLOR....html?x=0&.v=1

They rang the opening bell at NYSE/AMEX on June 3rd. http://finance.yahoo.com/news/Spence....html?x=0&.v=1

Okay, I can stop now with the FA attempt. Let's go to the TA:

The hype associated with the presenting and ringing above must be giving the stock a boost.

Pete, I'm not going to post the charts here because you can read them as well as me. The stock gapped up (daily) on June 1st and continued up June 2nd on above average volume, probably in anticipation of the bell ringing. Then it hit the resistance (6.32) that first became apparent on 5/12 (6.34). Double top. Wonder if the buyers of the March stock offering decided it was time to take profits. Since then, more profit-taking on above average down volume.

That was a lot of stock they offered in March. It may take a while for this profit-taking to work itself through. Also, on the weekly 6.34 looks like the end of the 5 up Elliott wave, and may be going into an abc correction.
Can only speculate if the pps will get a boost from the Tuesday June 8th presentation. If it does, I would look for more profit-taking.

This is a great company Pete with a whole lot of great connections, money, and a business plan. Any announcement about a potential new partnership, etc. would surely give it a boost. But, in the meantime IMHO, it needs to work thru the resistance. If it breaks it decisively on big volume, with an announcement impetus, I'd get in. Good luck, and thanks for bringing it here.

River thanx for such a great analysis , I have not bought it yet but seriously looking.

[tiedyed1]

re: Delcath and ASCO

Hi River;

It appears there are some negative news at ASCO re: Delcath.

Delcath's drug delivery system helped melanoma patients whose cancer had spread to their liver, live more than three times as long as patients treated with best available care. But one researcher said the system causes "a fair amount of toxicity" and would need to be used only at centers with expertise in monitoring patients.

Is this that unusual? I would think that any kind of treatment like this would have serious toxicity where it would require monitoring, wouldn't it?

Stock back down to $11. Is this a buying opportunity or a hold and watch?
You thoughts?

Thanks again. I really appreciate your information and feedback!

-Adam

[riverbabe]

Dcth

Hi River;

It appears there are some negative news at ASCO re: Delcath.

Delcath's drug delivery system helped melanoma patients whose cancer had spread to their liver, live more than three times as long as patients treated with best available care. But one researcher said the system causes "a fair amount of toxicity" and would need to be used only at centers with expertise in monitoring patients.

Is this that unusual? I would think that any kind of treatment like this would have serious toxicity where it would require monitoring, wouldn't it?

Stock back down to $11. Is this a buying opportunity or a hold and watch?
You thoughts?

Thanks again. I really appreciate your information and feedback!

-Adam

The negative comments at the meeting weren't about the toxicity, although the problem was severe neutropenia and infection because there was leakage from the device into the blood stream/bone marrow. Instead, the comments were that there are only about 1000 patients in the USA that could even use the treatment. The rebuttal was that there is a tremendous market in Asia.

There was some discussion in the media about it possibly being overpriced at the present level. The investors are mostly retail, not institutional. They call us the "Delcathians." Because of the potential market and pricing discussion, I expected it to go down today. I am planning on averaging down soon. Maybe not today...wait to see the dust clear a little. Better buying opportunity soon I think.

[riverbabe]

Dcth again

Another case of investor panic? Another finicky biotech stock? You need nerves of steel to invest in them, folks. Disclosure: I am a Delcathian, still holding long, although in the red. Probably will add very soon.

This is more information, including a great video. Stock stabilizing at this hour.

Wall Street Media Presents Eric Whitman, MD on Delcath's Positive Clinical Results

Companieselcath Systems Inc. Related Quotes
Symbol Price Change
DCTH 11.25 +0.42

Press Release Source: Wall Street Media On Monday June 7, 2010, 5:45 pm EDT
NEW YORK--(BUSINESS WIRE)--Wall Street Media presents an exclusive video of Dr. Eric Whitman, a highly regarded surgical oncologist who specializes in melanoma and is Director of the Atlantic Melanoma Center. Dr. Whitman attended the American Society of Clinical Oncology’s (ASCO) Annual Meeting, where he took special note of a presentation on Delcath’s (NasdaqCTH - News) PHP study. Dr. Whitman stresses that PHP has proven to be clinically effective.

Please visit the following link to view the video:
http://wsmco.com/show.aspx?1661_Very...e_DCTH_Results

Delcath's PHP clinical trials have focused on a certain melanoma spread to the liver.

Some key factors we think were overlooked or misunderstood in today's market action are:

Survival rate tripled for cancer patients treated with PHP (Percutaneous Hepatic Perfusion) - 398 days vs. 124 with best alternative care
The data was even better than the initial press release from April. The hepatic PFS (primary endpoint) was 245 days in the PHP arm and 49 days in the BAC (best alternative care) arm
$745 million is the estimate for peak annual U.S. sales, if PHP is approved by the FDA
Potential increase to $5.6 billion if this treatment is used in primary liver cancer as well as metastases from other types of cancer

We discuss the vast potential for Delcath's PHP system:

The majority of the cases are not in the US, 80% of liver cancer is in Asia
The possibility for huge "off-label" use
The possibility for Delcath's PHP system to be used for many other cancer treatments in future

On his blog at http://drericwhitman.wordpress.com/ Dr. Whitman states "There is no question in my mind that this is clinically effective."

Hmm...posted this and the smilies showed up. They must have been hidden in the text. Somebody's idea of some fun?

[TheRelapse]

Thanks a lot for the recommendation of PBTH, I bought yesterday near the low, after it broke through the ~$6.30 resistance level, and it's up a nice 20% or so already.

I'm interested in what you guys think is a good target price. I'm thinking somewhere around $9 for the short term, is that too optimistic? I'm basing this on the huge momentum and the steadily increase in volume. Longterm, the fact that TEVA paid $400 million for a technology that is very similar to what Prolor is developing makes me think this company could reach a 1 billion market cap early into next year.

I am really clueless when it comes to biotech, but Riverbabe said the technology was solid and I know all the technicals are pointing up. Riverbabe since you really seem to understand all this medical stuff, how similar are the HGH trials that Cogenesys(the company teva bought) was performing to the ones being run by PBTH. Also, how much of Cogenyses' value was viewed as being in those trials? I feel this is a big key in evaluating PBTH. 1 last question, since this company seems to be in development stages of a bunch of drugs and treatments, how high risk is this company and is it a good takeover candidate?

Summary: I bought PBTH knowing it would be great short-term and am now thinking it may be really good long term.

I decided to start posting instead of just reading because I read some complaints of the low number of posts lately on the forum by some of the regulars. I'm 21 years old and have been investing for 5 years. I have a lot to learn but I hope I can bring something to the table.

I know I type too much.

I couldn't get my avatar to work either.