RiverBabe's Baby Biotechs

[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]

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.

[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!

[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

[steelman]

River,

Thank you so much for the nice write up/analysis. It is very helpful especially since I don't fully understand biotechs. Having you in our corner sure helps. I will stay out but will keep an eye on it. Best of luck this week in this crazy market.

[riverbabe]

Scln

Hello Steelman,

I have looked at SCLN. As with so many of these biotech pharma stocks, the credentials of the management and BOD are impeccable.

The news release of the data presented yesterday at the Rodman & Renshaw 6th Annual Global Healthcare Conference in London is positive, as far as it goes. ("SciClone Provides Clinical Program Update for SCV-07 for the Prevention of Oral Mucositis in Patients With Advanced Head and Neck Cancer. Company Establishes Scientific Advisory Board for SCV-07 in Oral Mucositis." http://files.shareholder.com/downloa...l_Releases.pdf). The reported results are of a Phase IIa "proof of concept" clinical study. http://en.wikipedia.org/wiki/Clinical_trial#Phase_II

"SAB members were encouraged by the findings from SciClone's phase 2 proof of concept study which suggested a consistent trend favoring patients in the trial's high dose group...Furthermore, the data from the study offered insight into study design for the next phase 2 trial."

Reminder: Phase III clinical study must be done and successful before submitting a new drug application (NDA) for approval by the FDA. So, this drug has a year or more of studies to go before FDA approval is obtainable.

But, the company has other drugs that are currently approved and in world wide distribution. Not only that, but the company is actually profitable and beat estimates in the latest quarterly report on May 6th. http://www.reuters.com/article/idCNS...0100506?rpc=44
However, the stock reacted negatively, with two high volume down days that more than filled the April 9th gap up and broke thru the 200 dma. A few buyers stepped in at that point, but it has currently broken down again, breaking the 50 dma and is sitting (as I look at the daily at about 1:30 PM today) on the 9 dma at 3.75. If the close breaks that, there is not much support down to the 200 dma. The weekly doesn't give me much confidence that it's going up either.

Maybe it's just general market malaise. But the positive earnings and the Phase IIa results have done nothing for this stock. Barring any surprise major announcement, I don't see this stock doing anything positive for a while unless it can be considered a takeover candidate.

My gut tells me this thing is going down! My bias, FWIW, is to watch and wait for lower price. (All MHO of course.)

[steelman]

Hi River,

I have been "eyeing" SCLN lately. It's currently priced at $3.96. Investools has a projected price of $16.66 which I love since I try and look for a 50% margin of safety so anything under $8.00 should be a steal. It seems fundamentally sound with good earnings, revenue and growth. The next strike price for options is $5.00. They also had some above average volume and had some news come out today about prevention of oral mucositis. If you have time, any thoughts on this one? Thanks.

[riverbabe]

Dcth

This is a link to a video of Delcath Systems ceremony ringing the opening bell of NASDAQ on May 14th. Go here and click on DCTH video link:

http://www.nasdaq.com/marketsite/marketsite_events.stm

Disclosure: I own quite a few shares of this stock. It's up >5% today.

[riverbabe]

Sqnm

SQNM up >10% today on volume. Somebody likes them!

[riverbabe]

Sqnm

Hey Babe,

I was thinking of throwing some money at SQNM and holding on for the next announcement. Wuddayathink?

I am very much enjoying this thread... some great insight and info here

Peanuts, first of all, I love the name of this company, Sequenom. They are sequencing genomes! Actually, one of their primary products is a prenatal test for trisomy 23, the gene for Down's Syndrome, but they are expanding their products both in hardware and software for detecting mutant genes by mass spectrometry and infrared-assisted mass spectrometry. So, they are essentially a mass spec + software sales company. In their 1Q earnings, they also list costs associated with licensing of IP related to age-related macular degeneration, which has to be a growing market. Anyway, I'm impressed.

http://www.sequenom.com/About-Us/Overview

http://www.sequenom.com/Genetic-Analysis/Systems/Hardware-and-Options.aspx

http://www.sequenom.com/Corporate/Intellectual-Property

The shareholder's suit against the company for an employee's "mishandling" of the trisomy 23 test data was settled when they fired the CEO, plus the former R&D chief, and several other employees. Wow. That, to me, shows a strong Board of Directors!

http://www.prlog.org/10229462-sequenom-inc-shareholder-lawsuit.html

http://www.xconomy.com/san-diego/2010/01/15/sequenom-settles-shareholder-lawsuits-for-14m-plus-stock/

And then I looked at the Leadership, the Board, the Advisors, the lineup can't be more impressive.

http://www.sequenom.com/harry-hixson

But see the following under Litigation Update: If the settlement becomes effective, Sequenom will issue approximately 6.8 million shares of its common stock in connection with the settlement. That spells some dilution. http://www.sequenom.com/Corporate/News

94 institutions holding or controlling over 40% of the shares: http://finance.yahoo.com/q/mh?s=SQNM+Major+Holders

So what happened to the share price on 5/12-13? A private placement: http://blogs.barrons.com/stockstowat...d=yahoobarrons and http://phx.corporate-ir.net/phoenix....ews&id=1425886 The private placement is "private!" "Sequenom, Inc. (Nasdaq: SQNM) today announced that it has entered into an agreement to issue and sell an aggregate of 12,435,000 shares of its common stock at $4.15 per share to certain investors. The aggregate gross proceeds of the private placement are expected to be approximately $51.6 million. Sequenom intends to use the net proceeds from the financing to advance its research, development and commercialization of various diagnostic tests, as well as for general corporate purposes. Subject to the satisfaction of customary closing conditions, the private placement is expected to close on or about May 17, 2010. The price per share of the private placement is well below the current stock price of 5.53 at close yesterday." And more dilution!

And what about this? Dr. Koster is a "founder of Sequenom." Is this not a competitor? http://finance.yahoo.com/news/caprot....html?x=0&.v=1 (second paragraph)

Peanuts, something is going on here. I can't see what it is, but judging by the craziness in the stock price, it might be worthwhile to wait until all the dust has settled. You can read the charts as well, or better, than I can. I personally would not invest here. But I sure would watch it. It comes across as a great company for a long term investment, but IMHO one would really have to be clairvoyant to read between the lines right here.

Best of luck, River.

[billyjoe]

River,
Great job and analyzation. But heck, you're worth the $299/month fee. Just kidding. You're priceless! Thanks again. Every Riverbabe post brightens my day.

-------------billy

[riverbabe]

Brli

Billy, BRLI appears to be a great company with great earnings. Av. vol. is high enough for my comfort level.

Again, this one is meeting resistance at roughly 24.67. It looks to be in an Elliott 1 up, possibly beginning a 2 down. But, the interesting thing is that, despite the high down volume yesterday, the price didn't drop very much. That would be a positive IMHO, meaning there are buyers supporting it at this level. The 5 min. on the daily charts show an uptrending stock for the last 2 days in a downtrending maket. Another positive. A high volume buyer was willing to pay 24.62 for it yesterday.

If it were to break above say, 24.75 or so, on big volume, it might be worth a buy and go into an Elliott 3 up. Stochastics heading up to overbought territory, but ADX now turned up (more accumulation than distribution, a definite positive). Again, good luck. River

[peanuts]

Hey Babe,

I was thinking of throwing some money at SQNM and holding on for the next announcement. Wuddayathink?

I am very much enjoying this thread... some great insight and info here

[riverbabe]

Trib

Billy, TRIB divested itself of its Coagulation business and this is seen as a big positive by Zack's who has rated it "outperform."

http://finance.yahoo.com/news/Trinit....html?x=0&.v=1 zack's initiated outperform

Q1 results just announced are great and forecast is improved. Not only that, they have paid off all their bank loans and have tons of cash in the bank!

http://finance.yahoo.com/news/Trinit....html?x=0&.v=1 Q1

They are going to concentrate on their "point of care" business which has been very profitable, except for a decrease over the past two quarters, which they explain (see Lyme Disease test, etc. etc. etc.).

Technically, they are a really low-volume stock, roughly 17k daily. I don't usually invest in anything under 100k daily because they are too hard to get out of once you get in. But, they have about 18 million US ADR's outstanding, which is reasonable IMHO.

I have annotated the following chart. There is strong quadruple top resistance where the price is now. If it can break through that on high volume, it has a chance to climb up an Elliott wave 3. I would wait for a breakout on volume before investing though. I don't know what the impetus would be for that, but institutional buying could produce it.

I have also attached a chart that shows the other indicators I use. The stochastics are getting up there close to showing overbought. The accumulation/distribution ratio (ADX) is showing slowing accumulation after the big ramp up on earnings.

All the best, River

[riverbabe]

River,
I've got 2 good ones for you. TRIB would get by as a baby biotech but BRLI probably wouldn't. BRLI looks awesome with great sales and earnings while TRIB has great earnings but a slight problem with sales. What do you think?

--------------billy

Billy, I am enjoying researching these! Right up my alley, except that they are not really pharma-related and in clinical trials, but you & Beth & I share a common interest here. So, with the caveat that I am definitely not a strong person on fundamentals, I know you are and that gives me confidence to look into them. Will get back to you.