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I agree that I think it will pass...
I also think it's already built into the price. While rarely would I support a RS, I think this may be a unique event. In the majority of cases, a RS is done by companies that have very little going for them. As for GTCB, I think we're now positioned for additional partnerships (the Ovation partnership strenghtens credability in the market) and positive news flow over the next year.
Having a stock at less than $1/share prevents most institutional investors from participating. The RS will allow them to get back into the stock and today's deal, combined with future news flow, will drive some higher institutional buying going forward.
Once the short timers sell off...
We're seeing the short term traders sell off today (they're not getting the short term windfall that had hoped to see). After that, I'd expect the stock to stabilize and begin to drift back up. For me, this deal further solidifies the fact that there are a number of well respected organizations out there that believe in the science of the company. The Ovations deal will just make it that much easier for other organizations to look at GTCB as a potential partner. As such, whether we get more cash via additional deals or, at some point, sell the organization outright, there's little doubt in my mind that there's a decent return to be had from these price levels.
We may be sold yet...
Obviously the market is concerned about the current cash situation. On the other hand, the stock is currently valued far below what I would expect the company to be worth if purchased by a strategic buyer. If a partnership (and some up front cash) doesn't materialize soon, the company may have no choice but to join a strategic buyer.
I don't know what we'd get on the market, but with the patents and science that's currently owned by this company (see post #8387), combined with the market opportunity, the current price isn't even close.
This company and it's science isn't going away. It's holds far too much intellectual property to not be picked up by someone along the way. While this would obviously prevent the upside of $3-$4 that some had hoped for, it would provide significant upside versus where we are today.
Dew...congrats on 30,000 posts (now go get some sleep)
P.S. - for the record, I never stated, nor believed, that companies can get materially better terms in a partnership deal by raising money during the negotiations as stated in your post. Rather, my point was that a company can end up with significantly worse terms, versus normal market conditions, if they're forced to negotiate during a period in which they have no choice but to get to a quick conclusion.
Why not a loan...?
Why didn't GTCB get a loan
I'm sure GTCB would love to have been able to get a loan. But since they don't have a consistent income stream, or any guaranteed source of funds to pay back a loan, it would never happen (especially in today's lending environment).
Even with equity, part of the reason that the financing announced today wasn't done earlier was that it was contingent upon successful top line results.
The bottom line is that no one's going to put in millions of dollars, even equity dollars, without some assurance of success.
You're welcome...
<One thing that I always wondered about when it came to posters relating their conversations with management of a company. By doing so, you will be compromising your screen name as it will be obvious to some (Newburry in this case at least) who you really are as a person as opposed to having an anonymous screen name. Does that not bother you?>
It doesn't bother me at all. I don't post anything on these boards that isn't either "what I've been told" (as with my conversation with Tom) or my personal opinions. As for my postings, I wouldn't post anything here that I wouldn't tell a company representative myself (which is exactly what I did earlier today with Mr. Newberry).
Hopefully this financing fiasco will pass, a partnership will be finalized, and we can get back on the path of building a valuable business.
>Newberry made the statement to me that they didn't want to let a potential partner feel that it was to their advantage to delay any deals. If a potential partner felt that the delay would drive GTCB's cash position into one of desperation, they'd delay as long as possible hoping to put themselves into a better negotiating position.<
Dew's response - With all due respect to Mr. Newberry (who is a good IR man, IMO), I interpret the above as propaganda. Newberry is saying this because he knows it’s the kind of story that will convince people who read message boards.
Dew - I suggested that this might be the logic behind todays financing way before I talked with Newberry (post 7778). I'm the CFO of a company and have been through a ton of negotiations over the years. "Delaying" the close of a negotiation is a classic move in situations like this. Trust me...if GTCB appears to be in a short term cash poor position, I'm going to leverage it for all I can. If on the other hand, it appears that GTCB is going to be okay for awhile, and may even have time to talk with other potential partners, I'm going to be more aggressive in getting to a conclusion.
As I said before, a partnership may not happen for awhile...but having extra cash on hand only improves the chances of getting to a successful result.
Why remove it?
There may actually be a better chance of getting a deal closed by March 31st than there was previously.
Newberry made the statement to me that they didn't want to let a potential partner feel that it was to their advantage to delay any deals. If a potential partner felt that the delay would drive GTCB's cash position into one of desperation, they'd delay as long as possible hoping to put themselved into a better negotiating position.
GTCB had hoped to actually do todays deal a couple of weeks ago when the market was in better shape. The delay was caused by the need for the top line results to come in positive in order to close the deal. Obviously, when the results were delayed, the financing was also delayed.
Will anything be done by the end of the 1st qtr., who knows...but I don't think today's deal is any indication that it's any less likely.
I received a call back from Tom Newberry...
(The fact that he called me back is an indication that I own too many shares...)
The call was informative. His key comments included:
1) Nothing has changed from a strategic perspective.
2) They are continuing partnership discussions but felt it was important to not be negotiating with a "dry" (cash poor)balance sheet. This financing buys them time to negotiate on a solid footing.
3) The delay in the partnership process at the end of last year was driven by their talking to more potential partner candidates, late in the process, than had been expected.
4) The financing was contingent upon their getting good top line results. While this indeed happened, the fact that the results got pushed back, and we ended up in a bear market, hurt the financing valuation.
There was nothing on the call to lead me to believe that partner discussions are in trouble. In fact I got the other sense, that there was increased opportunity due to interest from multiple potential partners. The only downside was the incremental time required to work through the process.
OKY - I'm with you...
I'm in almost exactly the same situation as you (both in your line of thought and % of loss)!
Obviously, I wish I would have pulled the plug along time ago...but I didn't. I stayed in because I believe in the "technology" and the opportunity - the ironic thing is that this is more true today than it was a few months ago.
I'm not getting out at this point. From my perspective it's a great time to buy for those that haven't been involved. With this cash infusion and a partnership arrangement somewhere down the road, a lot of the preceived risk will diminish and it will head back up.
Called Tom...
I was probably on the phone at the same time you were writing the message. I got his voicemail which isn't surprising. It's the first time I've ever called. I left my number but said I really wasn't expecting a call back. Basically, I just expressed my dissappointment in both the deal, the fact that we've lost over 25% of the companies value in 2 days, and the overeall lack of communication as to their strategy and conflicting communications.
What's killing this stock isn't their business model, it's how they're handling investor communications and financing.
The right partner at the right terms...!
If todays financing allows GTCB to buy the time to insure that a solid, financially sound, partnership is developed, then it's a good thing.
Whatever partnership develops will likely last for years...and the terms established now will drive the company for a signficant period to come. They need to do it right.
Being forced to jump into a partnership for the sake of meeting short term cash requirements would be a major long term mistake.
Why now...?
Like everyone else, I'm a bit surprised by today's action. While I don't like dilution, I'm still focused on what this company can become over the next couple of years.
As for "why now", and not after, a partnership agreement, the likely answer is that GTCB was getting squeezed by a potential partner(s). If the partner was negotiating knowing that the company has a short term cash issue, they were probably leveraging it to the hilt to drive the best deal possible (for them...not GTCB). This cash infusion buys time to either look at alternative partners, or simply buy time to negotiate the best possible deal.
The general concensus with many on this board is that the company should have a market value of at least $300-$400M. The intellectual property rights alone have significant value. The only real issue is having the cash to get through the next year or so and insure that there are partnerships in place to help fund on-going activities. Even with today's deal, the outstanding share count for valuation purposes would be under 125M (with all warrants counted). At a value of $350M, it creates a share value of $2.80.
To sum it up, there is still a lot of opportunity in this stock over the next 1-2 years.
Let's keep it simple...
Per the valution review below (a third qtr 2007 review), product based biotech firms had M&A revenue multiples of 10.4x.
Hmmm...using only the $75M in revenue figure, it would mean that we'd be looking at $750-$800M. If you use 100M shares outstanding, it takes us to $7.50-$8/share. Are there risks? Sure, but they're being minimized every day. More importantly however, there are some huge opportunities that aren't factored into any of the above.
You can discount it any way you want - it's why I'm in big.
www.scottmaconltd.com/images/publications/SM3Q07%20Healthcare%20Review.pdf
I'm glad my #2 theory was correct!
Nothing but upside from here (...I may be able to retire yet!)
It may be good...
1) If they had the news...and it were bad...they'd be setting themselves up for potential legal issues by not disclosing.
2) If they have the information...and it's not bad...they can take their time framing if for disclosure.
IMO, if they had bad news their attorneys wouldn't allow them to sit on it for any length of time.
I thought I'd pop in. I haven't been here for awhile and now that I've read some of the posts, I remember why. Very simply, I've owned GTCB for a couple of years and have acually added significantly to my holdings over that time. The key however is that I'm in it for the long haul - 3-5 years at least. I'm an investor - not a trader. Do I like where the stock price is today - no. Do I like what I see as to the opportunity that lies ahead in the next couple of years - absolutely.
The bottom line - if your an investor, nows a great time to get in. If your a trader, stay on this board, follow all the hype (both up and down), and good luck.
GTCB - So What To Do?
Now priced at $1.35 with a ton of uncertainty hanging out there. I'm now out (sold 1/3 yesterday and the rest today). I have to admit that I'm still not sure I've done the right thing (except for the "sold 1/3 yesterday" part). The science is still solid yet today's decision will almost cartainly impact the value of the company (additional dilution, a fire sale, etc. etc.)
I still believe in the science but am struggling with the investment. I'll keep watching and may be back.
For all of you that added your insight along the way, thanks! Personally, I think the comments on this board were right on. I was in the camp that believed in an 80% chance of approval. Oh well, maybe next time.
NFLD strongly disputes WSJ article
http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=820512&highlight...
Northfield Laboratories Strongly Disputes Wall Street Journal Story Conclusions
EVANSTON, Ill.--(BUSINESS WIRE)--Feb. 22, 2006--Northfield Laboratories (Nasdaq:NFLD) released the following statement in response to a Wall Street Journal article on the company published today: Today's Wall Street Journal article, "Amid Alarm Bells, Blood Substitute Keeps Pumping" contains several errors of fact and misinterprets the Acute Normovolemic Hemodilution (ANH) clinical trial protocol and results. We particularly disagree with the characterization that Northfield Laboratories did not disclose the results of this clinical trial or discouraged others from publishing its results. In fact, we believe that prompt publication of all the study data would have been favorable to Northfield Laboratories.
"We made no effort to discourage the publication of ANH data and in fact, three publications have resulted from the study with the fourth expected soon," said Steven A. Gould, MD, Chairman and Chief Executive Officer of Northfield Laboratories. "We believe that publishing the full data upon closing the study, would have shown that PolyHeme could not be isolated as the cause of the observed serious adverse events."
The ANH trial described in the article as the abdominal aorta aneurysm trial was conducted in the late 1990s and was a complex study involving a difficult and unusual procedure in a high risk population from whom individual consent was obtained. The protocol resulted in the PolyHeme patients' having 60 percent of their blood volume withdrawn versus 30 percent in the control group. In keeping with the protocol, the PolyHeme group also received substantially more fluids than did the controls resulting in complex issues with fluid management in those patients. Even so, serious adverse events were not uniformly observed in the study. In our concurrent trauma trial PolyHeme was being administered to rapidly bleeding patients in doses of up to 20 units (or twice the blood volume of an adult) without these findings. Furthermore, as there was no evidence of ischemia upon intraoperative EKG studies in the ANH patients, we believe it is unlikely the outcomes in the ANH trial are due to a pharmacologic effect of PolyHeme.
Because we experienced difficulty in enrolling the number of patients required to complete the study in a timely manner, with FDA approval, we wound down the study over a period of months, not abruptly as the article states. The trial closed in 2000 and the full data were reported to the FDA.
Lead ANH trial investigator Edward Norris, MD of Johns Hopkins University Hospital, will present the full study results at the Network for the Advancement of Transfusion Alternatives (NATA) meeting in April 2006. We believe his presentation will substantiate our conclusions as does our extensive experience with PolyHeme in trauma settings.
Northfield is currently conducting a national trial with PolyHeme in the trauma setting. This trial, which began in 2003 was approved by the FDA and 32 Institutional Review Boards at Level I Trauma Centers for patient enrollment after they reviewed the protocol and the results of all previous trials with PolyHeme.
"We believe the markedly different experiences with PolyHeme in the ANH and trauma trials can be attributed to the entirely different protocols, settings, and populations in these studies," said Gould. "To suggest the ANH data were withheld to further the trauma trial is patently untrue and damaging to both Northfield Laboratories and PolyHeme."
Every investigator and every IRB at every site involved in the current trauma trial was fully informed of the results of all of Northfield's prior trials. Because the trauma trial is being conducted under a Federal regulation allowing for a waiver of informed consent, communities participating in the study have been engaged in ongoing discussions with investigators regarding the trial. Northfield made no effort to dissuade centers from presenting previous trial information in any of their community outreach efforts.
The current trauma trial has passed four interim analyses of the mortality and serious adverse event data by the Independent Data Monitoring Committee (IDMC) charged with its oversight. The last review occurred In November 2005 after the first 500 patients had been enrolled and followed for 30 days. Had a safety issue been identified, the IDMC would have recommended we either modify the protocol or stop the study. After each analysis the IDMC recommended that the study continue without modification as there were no safety reasons to alter the protocol.
NFLD - Typical Overreaction
Dew - One can never be sure however in this case;
1) The WSJ article is referencing a prior study that took place years ago.
2) The present study appears to be going very well. I'm sure that the FDA is watching closer than ever based on the issues related to study #1.
3) FDA must have agreed that the first study deaths related to problems with how doctors "prescribed" the product versus the product itself (resulting in too much liquid being pumped into the body). The current study seems to be confirming this.
4) The product doesn't have a viable alternative that is relatively risk free. It will also provide a significant solution to the "supply & demand" issues currently being faced.
Bottom line is that management screwed up in their lack of communication. The deaths apparently were not the result of the drug, but more likely the result of misapplication by doctors. My sense is that the current study, and ultimate results, will quickly over shadow the WSJ article. In fact, the current article may help bring in investors that were previously unaware of the companies potential.
I picked up a nice chunk of shares this morning in the low $9.90's. Still predict back to $12 in a week (though I've been wrong before..!!).
NFLD - Typical Overreaction
My guess is that it's back to $12 within a week.
GTCB/CBS - You can watch it here
http://www.cbsnews.com/sections/i_video/main500251.shtml?channel=eveningnews
Preciouslife1...Unfortunately not!
Lived for ten years in the Lakeland/Winter Haven area. We spent many weekends in St Armands however as we loved hanging at the beach and hitting the shops and restaurants.
Currently living in the Charlotte NC area so we don't get down there near as often as I'd like. Another couple of years (and a few approvals on the part of GTCB) and I'll be down there a lot more often...!!
Best wishes!
GTCB - CBS
New video promo on CBS news site about tomorrow's story - and they just ran it on Sixty Minutes. Still not confirmed that it's GTCB but it sure looks good.
News story is likely about -
http://www.atiii.com/patientvoice.htm
Should be an interesting week.
New Patent Issued to EntreMed for 2-Methoxyestradiol Analogs
Patent Covers Novel Antiangiogenic Compositions
Last Update: 7:31 AM ET Feb 14, 2006
ENMD, a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammation, today announced the issuance of U.S. Patent No. 6,995,278 covering analogs of its lead compound, 2-methoxyestradiol (2ME2 or Panzem(R)). Panzem(R) is currently in clinical trials for cancer, as well as in preclinical development for inflammatory disorders.
The patent grants EntreMed composition-of-matter intellectual property protection through 2020 for analogs of 2ME2 in oncology and a broad range of non-oncology indications, including inflammatory and immune disorders, rheumatoid arthritis, and other diseases characterized by abnormal cell division (mitosis).
Panzem(R) is a novel anticancer agent, which is part of a next generation of antimitotic cancer drugs that bind to tubulin and work through multiple cellular pathways. 2ME2 can attack tumors on multiple fronts -- directly by disrupting microtubules, an intracellular matrix necessary for the rapid division of cancer cells (mitosis), by inducing programmed cell death (apoptosis), and by blocking blood vessels that feed tumors (angiogenesis inhibition). Analogs of 2ME2 have been developed by EntreMed to decrease metabolism while retaining their antiproliferative and antiangiogenic properties.
James S. Burns, EntreMed President & Chief Executive Officer, commented, "EntreMed is focused on the development of a new generation of small molecule drugs for the treatment of cancer and inflammatory disorders by attacking disease cells directly and the blood vessels that nourish them. This patent and other pending patents are the result of an extensive internal program to identify new antiangiogenic compounds based on EntreMed's expertise in angiogenesis, cell cycle regulation, and inflammation. This patent further strengthens our intellectual property position in next generation antimitotic and antiangiogenic drugs for the treatment of cancer. ENMD-1198, the lead compound resulting from our analog program, currently has an active IND and we anticipate initiating a Phase 1 clinical trial in cancer this quarter."
U.S. Patent No. 6,995,278 entitled "Antiangiogenic Agents," covers analogs that have been modified at certain positions on the 2-methoxyestradiol structure, yet retain their ability to inhibit cell proliferation. In addition, the '278 patent claims methods for modifying 2ME2 to obtain the analogs and for treating diseases or conditions with compounds having the claimed structural modifications of 2-methoxyestradiol. The '278 patent covering the issued claims is owned exclusively by EntreMed.
VION - Bladerunner
Thanks Bladerunner....
VION has turned out okay so far. I got in at $1.90 a week or so ago and it closed today at $2.20. Looking at the charts it could still have a ways to go. Thanks.
VION - Bladerunner
Thanks for the response. I'll take Dr Garren's support (and any other for that matter) since I added a pretty good chunk to my portfolio.
I'm not a big science guy but I like their prospects. With where they're currently positioned, potential upside versus risk looks very good.
Go Dr. Garren...!!
ENMD - Celgene (CELG)
Interestingly, one of the investors in todays financing with ENMD was Celgene.
P.S. - Dew - I agree with your comment.
EntreMed to issue units under private placement (ENMD)
NEW YORK (MarketWatch) -- EntreMed Inc. (ENMD) has agreed with institutional investors to privately place units consisting of shares of common stock and warrants at a purchase price of $2.3125 per unit. The company will issue approximately 13 million shares of its common stock and warrants to purchase up to 6.5 million additional shares of common stock at an exercise price of $2.50 per share under the placement. EntreMed intends to use the proceeds from the offering primarily for further clinical development of the company's lead oncology drug candidates as well as further development of its preclinical pipeline candidates.
Closed yesterday at $2.26
VION - Any thoughts?
Am looking to put some money into VION today. Appears to have limited downside and is still at a great price point. Would appreciate any comments. Thanks
Vion Pharmaceuticals, Inc., a development stage company, engages in the development of therapeutics for the treatment of cancer. The company has two small molecule anticancer agents, including CLORETAZINETM (VNP40101M) and Triapine, in clinical development; and other small molecules and a drug delivery system, including KS119W and heterocyclic hydrazones in preclinical development. Its lead product candidate CLORETAZINETM (VNP40101M), which is in Phase II single agent trial, is a sulfonylhydrazine alkylating agent for the treatment of relapsed acute myelogenous leukemia. Triapine is a small molecule that inhibits the enzyme ribonucleotide reductase, and prevents the replication of tumor cells by blocking a critical step in DNA synthesis. Triapine is in Phase II combination trial with gemcitabine in pancreatic cancer. KS119 is an additional cytotoxic (cell-damaging) compound from the sulfonylhydrazine class. Heterocyclic hydrazones are anticancer compounds that have demonstrated potent antitumor effects. It also has one product development program, TAPET (Tumor Amplified Protein Expression Therapy), a drug delivery system using modified Salmonella bacteria, which is designed to deliver anticancer agents directly to solid tumors. Vion Pharmaceuticals has a collaboration agreement with the National Cancer Institute for the clinical development of Triapine.
VSGN - Vasogen's Phase III SIMPADICO Results to be Presented at Late-Breaking Session of the 55th Annual Scientific Session of the American College of Cardiology
2/1/2006 6:01:01 AM
TORONTO, Feb 01, 2006 /PRNewswire-FirstCall via COMTEX/ -- Vasogen Inc. (VSGN), a leader in the research and commercial development of technologies targeting the chronic inflammation underlying cardiovascular and neurological disease, today announced that the pivotal phase III SIMPADICO trial in peripheral arterial disease (PAD) has been accepted for presentation at a Late- Breaking Clinical Trial session of the 55th Annual Scientific Session of the American College of Cardiology (ACC). The ACC meeting, which is being held in Atlanta from March 11 to 14, 2006, attracts approximately 20,000 cardiovascular professionals from the United States, Canada, and the rest of the world
ENMD/MKC-1 cellular target?
I don't recall it being discussed anywhere. Probably lost in all of the changing of hands. I'm at work right now (my real job) but I'll take a look later and see if I can find anything.
MKC-1 is an orally-active, novel, small molecule, cell cycle inhibitor with a unique mechanism of action. Specifically, MKC-1 arrests cellular mitosis by inhibiting a novel intracellular target important in cellular trafficking that has been shown to be involved in cell division. In preclinical studies, MKC-1 demonstrated impressive activity in a broad range of tumour models.
EntreMed Initiates Multi-Center Phase 2 Study with MKC-1
MKC-1 to be Tested in Advanced and Metastatic Breast Cancer Patients
1/25/2006 7:01:08 AM
Jan 25, 2006 /PRNewswire-FirstCall via COMTEX/ -- EntreMed, Inc. (ENMD), a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases, today announced that it has initiated Phase 2 studies with MKC-1. The single-arm, open-label study will be conducted at approximately 15 centers in the United States. Patients with advanced or metastatic breast cancer who have failed conventional therapies are expected to be enrolled. MKC-1 is a novel, orally- active, small molecule cell cycle inhibitor with a unique mechanism of action. Specifically, MKC-1 arrests cellular mitosis by inhibiting an intracellular target important in cellular trafficking that has been shown to be involved in cell division.
MKC-1 belongs to a novel class of antimitotics and apoptosis-inducers with in vitro efficacy against a wide range of tumor cell lines, including those exhibiting multi-drug resistance, as well as in vivo activity against a number of multi-drug resistant cell lines. MKC-1 has been shown to inhibit mitotic spindle formation, prevent chromosome segregation in the M-phase (mitosis) of the cell cycle, and induce apoptosis in multiple cell lines, consistent with a mechanism in which MKC-1 blocks the nuclear uptake of proteins essential to cell replication.
MKC-1 has demonstrated broad-acting antitumor effects in multiple animal models, including paclitaxel-resistant models. MKC-1 was evaluated in several Phase 1 and 2 clinical studies prior to its acquision by Miikana. These studies resulted in extensive pharmacokinetic and safety data.
S. Gail Eckhardt, M.D., Professor of Medicine at the University of Colorado Heath Sciences Center and cofounder of Miikana Therapeutics commented on the initiation of the study, "The initiation of this trial represents an important milestone in the development of MKC-1. A careful review of previous clinical data in 269 patients who participated in earlier Phase 1 and 2 clinical studies led to the conclusion that the recommended Phase 2 dose of MKC-1 on a 14-day schedule could be administered safely to advanced cancer patients, in contrast to earlier studies that resulted in excessive toxicity (4-day schedule) and an a priori reduction of the dose in the phase 2 NSCLC and breast cancer studies. Even at a lower dose than that recommended in Phase 1, a prior Phase 2 study involving 35 advanced breast cancer patients showed evidence of antitumor activity on the 14-day schedule, including two partial responses (10 and 14 months), two minor responses, and four patients with stable disease for four or more cycles."
Carolyn F. Sidor, M.D., M.B.A., EntreMed's Vice President and Chief Medical Officer, said, "We are pleased to hit the ground running with the Miikana team. The addition of MKC-1 to EntreMed's clinical pipeline is consistent with our expertise in cell cycle regulation and our continuing emphasis on anticancer agents with novel mechanisms of action." According to Sidor, EntreMed, on a combined basis in 2006, will have two oncology product candidates in Phase 2 studies (currently MKC-1 in breast cancer and Panzem(R) NCD in glioblastoma with other indications planned for both compounds in 2006). In addition, EntreMed's pipeline includes a Phase 1 oncology compound (ENMD-1198), together with a preclinical pipeline of novel compounds, including 2ME2 for the treatment of rheumatoid arthritis, an aurora kinase inhibitor in oncology, and an HDAC inhibitor in oncology.
James S. Burns, EntreMed President and Chief Executive Officer, concluded, "MKC-1 is our second product candidate to enter Phase 2 clinical trials this year. As a result, we have strengthened our clinical portfolio and repositioned EntreMed as a solid mid-stage clinical oncology company. Going forward, we will continue to maintain a lean infrastructure in support of our key clinical and preclinical programs, focusing internally where we can provide unique value and outsourcing what is readily available. On a consolidated basis, including taking the Miikana acquisition into account, we anticipate that our 2006 net operating expenses will be approximately $30 million which is an increase over 2005 and associated directly with advancing our clinical and preclinical programs."
For information on this study, visit the Clinical Trials section of the Company's web site at http://www.entremed.com.
About EntreMed
EntreMed, Inc. (ENMD) is a clinical-stage pharmaceutical company developing therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem(R) NCD (2-methoxyestradiol or 2ME2), the Company's lead drug candidate, is currently in clinical trials for cancer, as well as in preclinical development for rheumatoid arthritis. EntreMed's goal is to develop and commercialize new compounds based on the Company's expertise in angiogenesis, cell cycle regulation and inflammation -- processes vital to the treatment of cancer and other diseases, such as rheumatoid arthritis. Additional information about EntreMed is available on the Company's website at http://www.entremed.com and in various filings with the Securities and Exchange Commission.
ENMD
Dew - I am currently holding some ENMD. I beleive that the price point is still attractive and management has been on target.
A poster on Yahoo today posted the following I believe he(she) is right on (tborges132)
One of the most encouraging comments to be made concerning the Burn's management team at EntreMed is their unfailing ability to establish and then achieve benchmarks. Burns-Sidor have been spot-on at achieving each of the stated goals of the past year. The commencement of Phase II studies at Duke is yet another benchmark.
While efficacy remains the big prize, we are now entering that part of the march to approval which will be all-telling.
Angioglioblastoma was one of the six indications targeted in Burn's letter of August 2005 in which he listed breast, prostate, ovarian, glioblastoma, multiple myeloma, and lung cancer as indications for multiple Panzem PII studies.
Based upon the indications noted, it is likely that the implementation of additional PII studies will follow.
The choice of Duke as the center for the current study appears to strengthen an alliance established with the previously announced Susan G. Komen grant for a Panzem study currently underway.
Do you want to know what will happen next? Pay attention to Burns... he has not missed a mark yet...
DOR BioPharma Reports Positive New Survival Findings from Previously Completed Phase II and III Clinical Trials of orBec(R); Results to be Presented at Upcoming BMT Conference this February 18th
MIAMI, Jan 20, 2006 (BUSINESS WIRE) -- DOR BioPharma, Inc. (DOR) ("DOR", or the "Company") announced today that as part of its process to submit a New Drug Application ("NDA") for orBec(R) (oral beclomethasone dipropionate) for the treatment of patients with gastrointestinal Graft-versus-Host disease (iGVHD) and in response to a specific FDA request, it has completed an analysis to compare the statistically significant survival benefit demonstrated in favor of orBec(R) in its pivotal Phase III clinical trial to the survival results of the earlier successful 60 patient, randomized, double-blinded, placebo-controlled, Phase II clinical trial of oral beclomethasone dipropionate for iGVHD.
Details of these new findings will be discussed by George B. McDonald, MD, inventor of orBec(R), at the annual Tandem Bone Marrow Transplant Meeting of the American Society for Blood and Marrow Transplantation and the International Bone Marrow Transplant Registry in Honolulu on February 18, 2006 in a presentation entitled "Oral beclomethasone dipropionate for gastrointestinal GVHD: a corticosteroid-sparing treatment with improved survival at day-200."
The randomized, double-blinded, placebo-controlled Phase II clinical trial of oral beclomethasone dipropionate in 60 patients with iGVHD was conducted and completed at the Fred Hutchinson Cancer Research Center in Seattle. The new follow-up data and analysis from the earlier Phase II trial suggests that the day-200 post transplant survival results from the Phase II study are in concordance with the approximate 70% reduction in mortality at day-200 post-transplant demonstrated in favor of orBec(R) in DOR's 129 patient, pivotal, multi-center, placebo-controlled Phase III clinical trial of orBec(R) for the treatment of iGVHD. In addition, the long term follow-up data from the Phase II clinical trial are also in concordance with the long-term survival benefit seen in favor of orBec(R) in the pivotal Phase III clinical trial. As previously reported, in DOR's pivotal Phase III study, there were 16 (24%) deaths in the placebo arm as compared to only 5 (8%) deaths in the orBec(R) arm at the prospectively defined day-200 post transplant mortality endpoint, achieving a statistically significant p-value of 0.011. Survival at day-200 was not, however, a prospectively defined endpoint in the Phase II trial and until recently so requested by the FDA, had not been previously analyzed.
The Phase II clinical trial was similar in design to the pivotal Phase III trial which was completed in late 2004. In the Phase II study, 60 patients with iGVHD were randomized to receive an induction course of conventional prednisone therapy plus either oral beclomethasone dipropionate or placebo. Initial responders continued to take oral beclomethasone or placebo for an additional 20 days, during which time the prednisone therapy was rapidly tapered. The primary endpoint for this study was the clinically relevant determination of whether iGVHD patients at Day 30 were or were not able to consume at least 70% of their daily caloric intake by mouth. The treatment response at study day 30 was 22 of 31 (71%) vs. 12 of 29 (41%) in the oral beclomethasone and placebo groups respectively, achieving a statistically significant p-value of 0.02. This data was previously published by Dr. McDonald in the journal Gastroenterology (1998).
DOR is also announcing today that in a recently completed analysis of the day-200 survival endpoint data from the pivotal Phase III clinical trial, it found that there were no previously undetected imbalances between the treatment and placebo groups that could have favored the orBec(R) group over the placebo group. In fact, there was a higher proportion of high risk patients in the orBec(R) group which would be expected to put the orBec(R) arm at a disadvantage. In spite of this, orBec(R) was still the factor with the strongest statistical association with survival.
"These new findings give credence to our belief that orBec(R) has a positive effect on survival in this patient population," said Michael T. Sember, President and Chief Executive Officer of DOR. "Since we missed our primary endpoint in the pivotal trial, the FDA has told us that a very high emphasis would be placed on our survival data. While the new preliminary Phase II survival results were not a prospectively defined endpoint, they are nonetheless supportive and corroborate the results from our pivotal Phase III clinical trial."
George B. McDonald, MD, Head of the Gastroenterology/Hepatology Section at the Fred Hutchinson Cancer Research Center, inventor of orBec(R) and a consultant to DOR stated, "We believe that orBec(R), a proprietary oral form of the potent site-active corticosteroid, beclomethasone dipropionate, may represent the first new therapy for iGVHD that improves survival. iGVHD is the most significant and life threatening toxicity associated with allogeneic hematopoietic cell transplants. orBec(R)'s topical activity in the gastrointestinal tract maintains control of the signs and symptoms of gastrointestinal GVHD, allowing prednisone exposure to be greatly reduced, resulting in fewer infections and better survival."
About DOR BioPharma, Inc.
DOR BioPharma, Inc. is a biopharmaceutical company addressing life-threatening side effects of cancer and cancer treatments, serious gastrointestinal diseases and disorders, and biomedical countermeasures. Our lead product, orBec(R) (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of intestinal Graft-versus-Host disease (iGVHD), a common serious complication of bone marrow transplantation for cancer, as well as other GI disorders characterized by severe inflammation. We plan to file a new drug application (NDA) with the FDA for orBec(R) for the treatment of iGVHD in the first quarter of 2006.
In November we announced that we entered into a binding letter of intent to acquire Gastrotech Pharma A/S, a Danish biotech company developing therapeutics based on peptide hormones to treat cancer and gastrointestinal diseases and conditions.
Through our BioDefense Division, we are developing biomedical countermeasures pursuant to the paradigm established by the recently enacted Project BioShield Act of 2004. Our biodefense products in development are bioengineered vaccines designed to protect against the deadly effects of ricin toxin and botulinum toxin, both of which are considered serious bioterrorism threats. Our ricin toxin vaccine, RiVax(TM), has completed the clinical portion of its Phase I clinical trial in normal volunteers. We have also announced the initiation of a new botulinum toxin therapeutic development program based on rational drug design.
For further information regarding DOR BioPharma, please visit the Company's website located at http://www.dorbiopharma.com.
Smith Barney’s Lucentis report:
I'd agree that Genentech has a great potential new product but where do you think the stock may go from here (it's at $90 and has more than doubled already in the last year)?
SNMX - Interesting Opportunity
Senomyx, Inc., a biotechnology company, engages in the discovery and development of flavors, flavor enhancers, and taste modulators for the packaged food and beverage industry. It primarily focus on the development of savory, sweet, and salt flavor enhancers, and bitter taste modulators. Senomyx has product, primarily flavors and flavor enhancers, discovery and development collaborations with Campbell Soup Company, The Coca-Cola Company, Kraft Foods Global, Inc., and Nestle SA. The company operates in the United States. Senomyx was founded in 1998 and is headquartered in San Diego, California.
They currently have a presentation available on their website that was given at a Needham conference this morning. It's interesting to me in that they are working to develop flavor enhancers that will allow food producers to produce healthier foods without losing taste. This isn't new. What is new is that they produce the product in a fashion that's very similar to pharmacutical development companies. Obviously, the benefit to their partners is that it allows them to sell a healthier product. They can help producers reduce sugar, salt, calories, etc. in their products without losing taste (or customers).
From a business model perspective, they get development funds from the major companies listed above and then once the product is put into a marketable product, they get ongoing royalties as the product is sold to the market.
Nice bump after today's presentation. We'll see where it goes from here.
>The cfo leaving shouldn't bother you because there weren't any revenues to screw around with.<
DNDN doesn’t have any material revenues either, and yet the announcement of the CFO’s departure there was a harbinger of poor performance for the stock.
As previously noted, among all of the top executives in a biotech company, the CFO has the least to gain and the most to lose by sticking around when there are problems not fully known to investors.
As a CFO myself, I concur with your above statement (it usually applies to any publically traded company - not just biotech).
Dew - my other holdings include....
My largest holding is GTCB (bought in at an avg. of $1.10)
Second largest is INSM (bought in at avg. of $1.26)
Other current holdings include DSCO, GENR, GPCB, and VSGN
While I'm certainly not a day trader, I tend not to be a long term investor (GTCB has been a long term hold for me). I tend to look for what I believe to be over reactions to news or other events. I buy, hold during periods of appreciation (attempting to protect any short term gains along the way), and usually sell off a portion for some profit along the way (I did this with both GTCB and INSM). What this means is that I'm not always looking to buy the best company - simply the best price opportunity at that time.
2005 turned out to be a very good year. I don't have the time to participate on these boards to the level I'd like but I'd like to thank yourself and all of the participants for the perspective gained along the way.
Here's to an even better 2006..!!
Dew - what about GPCB?
I know it's listed as one of your favorites so are you long, out or..??
I'm still holding a fairly large chunk so I'm just curious.
Thanks and good luck in '06.