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Colossal takeovers...
Is it time for someone to bring this up to Management at the annual meeting and discuss whether it makes sense for them to hire an investment banker (i.e., Goldman Sachs) to pursue strategic opportunities? One would think GTCB could get a 200+% takeover premium which isn't the return most shareholders on this board are looking for however, if it helps GTC reach its full potential then who are we to stop it (JMHO).
10nis
TRCA
<Ipsen to Acquire Tercica for $9 per share in cash>
Another 100+% takeover premium.... Who's next? MNTA, IDIX, GTCB, etc.?
10nis
Reverse Split
Another company up a lot since its reverse split in 2006 is SQNM, FWIW.
10nis
Taken out at 4 times cash levels? I'm sure MDT purchased REST for its cash... Who bases an acquisition of a micro cap
on its current cash levels? Anyways...
The point I was making was REST needed cash and so does GTC. REST's shares fell significantly in price and they were taken out for a significant premium while consistent with its previous trading levels. I was just stating I wouldn't be surprised to see a similar acquisition of GTC (i.e, being acquired around $1.50 which is a significant premium yet consistent with previous trading levels). It's anyone guess what will happen however if there were a time to take out GTC it would seem to be now.
10nis
<< My point about the "bum" analogy is that we are in a very weak position to negotiate with our current financial situation. Do you see a hole in this? >>
Weak position only if there is one potential partner/bidder and if we believe Cox that is not the case. IMO, GTC will see either an acquisition like Restore Medical (REST) received or it will obtain a partner (financial or otherwise). Kind of surprised Pharming hasn't made a move to acquire GTC.
http://biz.yahoo.com/ap/080423/restore_medical_last_call.html?.v=1
10nis
Thurly,
I don't think your buddies know what they are talking about because the deals I'm working are closing without a problem - they must be talking about very large deals. The key is most middle market deals don't get financed through a major bank and thus have not been materially impacted from the credit crisis besides tighter terms (this has been the case throughout the year).
The current credit crisis should have virtually no impact on any deal GTC strikes. GTC just needs to find the right partner and as they say, "git-ir-done!!"
10nis
Thurly,
I provide buyside financial due diligence services for private equity and strategic clients and every deal that I haven't help kill has closed. The middle market deals anything below $2 billion are getting financed without any problems. Capital is a little more expensive than it was 6-9 months ago (obviously) however financing isn't an issue for these deals. The credit market is extremely tight on anything over $2 billion.
With that said, I see no issues from the credit markets hurting GTC. The key is finding the right partner and getting the right terms.
10nis
GE would seem like a logical partner....but any cash rich company or a PE shop will do and there's plenty of cash sitting on big pharma balance sheets. Maybe Soros Capital???
So, the partner could dish out cash to fund operations in return for 50% of potential revenues for the currently un-partnered portions of programs and any future programs or something like that? That would beat buying GTC since they would have to purchase the company ($100+ million), fund operations and also face the risk of failure. In this case, they have a call option on the success of GTC with a total loss equal to cash to fund the operations.
One would think GTC's shares would fly on a deal like this since it gets the cash it needs without dilution and as long as they don't have to give away too much revenue its a win-win situation for everyone involved. Management can then focus on finding more ways to apply its IP (vs. how it can raise cash).
Dew, what are your thoughts about a financing partner?
TIA,
10nis
<<< Whichever way you slice it, Cox and company haave been a business disappointment over the last year and we have all been somewhat scammed by the promise of the technology with a horrible business plan execution... >>>
Horrible business plan execution? Because they couldn't close one deal? Give me a break... Management has executed on its plan as well as one could expect unless you think you could do a better job. Sure there was some slippage however that's going to happen and one deal didn't get closed. The last dilution hurt however nobody expected a credit crisis like the one we had. So overall management has done a decent job everything included and I'm confident they will get a partnership deal done.
Shouldn't we all be buying shares at these low prices?
10nis
<< It is reality. I hope I am wrong, but it seems to be the case. >>
Why do you post this crazy non-sense talk? Seems to be the case? Based on what - your insane thinking? If you cannot sleep holding GTC shares then sell them and move on. Otherwise spend your time being productive vs. wasting this boards time with your garbage posts.
A partnership deal will get announced and IMO, it'll greatly help to shore up GTC's financial position and give current shareholders a very optimistic view of the future.
Good luck,
10nis
One would think similar DD would be done by all potential partners and thus similar information has already been pulled, compiled, etc. Meeting with management, facility walk-thru's, etc. need to be completed however, those can take place over a couple of weeks at most. Its probably in the best interest of everyone to give management another quarter or two to see if they can complete a partnership deal on decent to good terms since it could mean a 100-200% move higher in the stock price.
If the technology works we have nothing to worry about since worst case a cash rich pharma takes us out for a song ($1-2 a share), IMO.
TIA,
10nis
<<< Undoubtedly the Proxy will be out and it will contain a request for a Reverse Stock split, which will not be a good thing but perhaps that aspect is already priced in the pps at this point... >>
The reverse stock split is a non-event. I also do not see a partnership announcement or major news event coming out of the CC but hope to be happily surprised.
I do think it would be in the best interests of the Company to hire Goldman Sachs or another firm to look into strategic initiatives/transactions... IMO, this would cause the stock to pop (most likely over $1) and the move would help to better price the shares with respect to any further financings as well as help to maximize shareholder value. I don't see how hiring Goldman could hurt the Company other than having to pay their high price fees.
10nis
Staranalyst,
There's a chance it just may. Question for you - why have you asked one sentence questions on 14 different boards today?
10nis
<<< Is it more likely that NVS starts slurping up shares on the open market or that they make and offer? What would be cheapest for them? >>>
Correct me if I'm wrong Dew, but NVS would have to file Amended 13D's if they purchase any additional shares as they own greater than 5% of IDIX. These filings would most likely trigger the market and thus, it would probably be easiest to purchase the remaining shares of IDIX it doesn't own with a large takeover premium, IMO.
10nis
IDIX
Wait until $9 when you could have bought it in the $2's? That's interesting logic. One would think it there's a big volume day (6-9 million shares) it'll be the day NVS purchases the remaining shares it already doesn't own which means you missed the boat.
I wish there were more plays like IDIX or MNTA... crash and back within a few months. I appreciate all your insight Dew. Have a great weekend!!
10nis
DJ Bristol-Myers, Medarex To Delay FDA Application For Ipilimumab
DOW JONES NEWSWIRES
Bristol-Myers Squibb Co. (BMY) and Medarex Inc. (MEDX) said they would delay filing the biologics license application for Ipilimumab, an advanced metastic melanoma treatment.
The companies said that the Food and Drug Administration requested additional overall survival data on the drug, and that they are working on a revised development timeline, but the application will not be submitted in 2008.
Bristol, a New York pharmaceutical giant, and Medarex, a Princeton, N.J., biopharmaceutical company, said they are working with the FDA to change the primary endpoint of Phase III trials of Ipilimumab to overall survival from progression-free survival.
Both companies said they are still committed to the drug's development.
Shares in Medarex plunged $1.03 to $6.98 in recent after-hours trading.
-Adam O. Manzor; 201-938-5400; AskNewswires@dowjones.com
GTC - Priority Review...
When should GTC hear about priority review? Looking forward to seeing a REST like move in the coming future....
10nis
IDIX news....
Press Release Source: Idenix Pharmaceuticals, Inc.
http://biz.yahoo.com/prnews/080423/new036.html?.v=46
Idenix Pharmaceuticals Presents Positive Preclinical Data on HCV Programs at The Annual Meeting of The European Association for the Study of the Liver (EASL)
Wednesday April 23, 8:00 am ET
CAMBRIDGE, Mass., and MILAN, Italy, April 23 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases, today announced preclinical data from the company's polymerase and protease inhibitor programs for the treatment of hepatitis C. These data are being presented at the Annual Meeting of the European Association for the Study of the Liver (EASL) being held this week in Milan, Italy.
Second-Generation Nucleoside Polymerase Inhibitor Program
IDX184 is a nucleotide prodrug derived from Idenix's proprietary liver- targeting technology. Results from in vitro and in vivo preclinical studies confirm that this technology preferentially activates IDX184 in the liver, potentially enhancing the antiviral activity of the drug and limiting systemic side effects. In an HCV replicon model, IDX184 exhibited 10 times greater potency than the first-generation HCV nucleoside clinical drug candidates currently in development. In HCV genotype-1 infected chimpanzees, once-daily oral administration of 10 mg/kg of IDX184 resulted in a mean viral load reduction of 2.3 log10 (n=5) after four days of dosing. No toxicities, including gastrointestinal or hematological, or abnormal blood chemistry were observed at oral doses greater than or equal to 600 mg/kg/day in a supporting seven-day toxicology study in cynomolgus monkeys.
IDX184 demonstrated additive antiviral activity in the HCV replicon in combination with HCV protease inhibitors and interferon and synergistic activity in combination with ribavirin. IDX184 also remained fully active in vitro against HCV containing known protease and non-nucleoside inhibitor drug resistance mutations.
Data from this program are being presented by David Standring, Ph.D., executive vice president, biology, Idenix Pharmaceuticals, in an oral presentation session at 5:30 p.m. CET on Friday, April 25, 2008, and by Erika Cretton-Scott, Ph.D., director, preclinical pharmacology at Idenix Pharmaceuticals, in a poster session beginning on Thursday, April 24, 2008.
Novel Macrocyclic Protease Inhibitor Program
Based on two novel macrocyclic scaffolds, Idenix has discovered compounds that demonstrated potency with subnanomolar antiviral activity against the HCV genotype 1b NS3/4A protease target and single nanomolar activity in the HCV replicon. These compounds also displayed high selectivity in vitro with no inhibition of selected human cellular proteases. In vitro, the Idenix protease inhibitors exhibited antiviral activity against certain HCV resistant mutants associated with first-generation protease inhibitors currently in clinical development. Pharmacokinetic studies demonstrated adequate oral bioavailability and sustained liver concentrations suggesting the potential for once-daily or twice-daily dosing. Data from this program are being presented by Dr. Standring in an oral presentation session at 6:15 p.m. CET on Thursday, April 24, 2008.
"The preclinical profiles emerging in our HCV nucleoside and protease inhibitor programs are very encouraging when compared to first-generation drug candidates from both of these drug classes," said David Standring, Ph.D., executive vice president, biology, of Idenix. "We plan to have product candidates from both of these programs in clinical development within the next 12 months with the goal to evaluate our own novel combinations thereafter."
IDIX
Coverage initiated at Caris & Company....
Idenix Pharma IDIX Caris & Company Buy $19
How many shares are outstanding currently for AVAN? Yahoo says less than 2 million... however, others say 15 million... Any help would be greatly appreciated.
TIA,
10nis
AVAN, PFE - AVAN only had a market cap of approximately $16-17 million prior to this announcement.... AVAN is up 49+% in AH's trading. AVAN is a goot example of a company that just had a reverse split that has gone up and tremendously. The reverse split occurred last month if yahoo is correct.
http://biz.yahoo.com/bw/080416/20080416006348.html?.v=1
Pfizer and AVANT Enter into Licensing and Development Agreement for Novel Therapeutic Vaccine Candidate for Brain Cancer
Wednesday April 16, 4:37 pm ET
NEW YORK & NEEDHAM, Mass.--(BUSINESS WIRE)--Pfizer, Inc (NYSE: PFE - News) and AVANT Immunotherapeutics (Nasdaq: AVAN - News), acting through its wholly-owned subsidiary Celldex Therapeutics, Inc. today announced that they have entered into an agreement under which Pfizer will be granted an exclusive worldwide license to a therapeutic cancer vaccine candidate, CDX-110, in Phase 2 development for the treatment of glioblastoma multiforme (GBM). This agreement also gives Pfizer exclusive rights to the use of EGFRvIII vaccines in other potential indications.
CDX-110, which has been granted both Fast Track and Orphan Drug designations by the U.S. Food and Drug Administration (FDA), is an investigational immunotherapy that targets the tumor-specific molecule EGFRvIII, a functional variant of the epidermal growth factor receptor (EGFR), which is a protein that has been well validated as a target for cancer therapy in certain tumor types.
EGFRvIII is only expressed in cancer cells and not in normal tissue and is a transforming oncogene that can directly contribute to cancer cell growth, as it does in about 40 percent of GBM tumors.
“We are excited about the potential for CDX-110 and intend to partner with AVANT and academic physician-scientists to investigate this novel vaccine candidate with the hope of providing patients and doctors with a new treatment option for this devastating disease,” said Dr. Briggs Morrison, Senior Vice President for Clinical Development at Pfizer.
Under the licensing and development agreement, Pfizer will make an upfront payment to AVANT of $40 million and will make a $10 million equity investment in AVANT. Pfizer will fund all development costs for these programs. AVANT is also eligible to receive milestone payments exceeding $390 million for the successful development and commercialization of CDX-110 and additional EGFRvIII vaccine products, as well as double-digit royalties on any product sales. The agreement is subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (as amended) and is expected to close in the second quarter of 2008.
“This partnership advances the therapeutic potential for CDX-110, particularly for patients with GBM. We are very pleased to initiate this relationship to expand our clinical development activities for GBM and toward other cancers,” said Ron Newbold, Ph.D., Senior Vice President of Business Development of AVANT Immunotherapeutics. Una Ryan, CEO of AVANT, added, “We see this as an important milestone for the immunotherapy field, and we look forward to Pfizer’s commitment to help even more cancer patients in the future.”
CDX-110 is designed to induce or enhance the body’s immune responses against EGFRvIII resulting in destruction of tumor cells that express the variant receptor. Early efficacy and safety data from single arm Phase 2 clinical trials of CDX-110 in combination with the current standard treatment for patients with GBM are very encouraging. Progression-free survival and overall survival data from these trials compare very favorably with historical control data. A randomized Phase 2 trial is ongoing.
GBM is the most common and aggressive form of primary brain tumor, with very poor prognosis. There are an estimated 10,000 new cases of GBM annually in the United States, which predominantly affects adults aged 45 to 70. The current standard treatment for patients with GBM includes surgical resection, radiotherapy with concurrent temozolomide and then adjuvant temozolomide chemotherapy.
NKTR, PFE
http://biz.yahoo.com/prnews/080409/aqw047.html?.v=53
Press Release Source: Nektar Therapeutics
Nektar Terminates All Negotiations With Potential Partners for Inhaled Insulin; Increased Number of Lung Cancer Cases Observed in Ongoing Clinical Studies of Inhaled Insulin Patients
Wednesday April 9, 8:30 am ET
SAN CARLOS, Calif., April 9, 2008 /PRNewswire-FirstCall/ -- Nektar Therapeutics (Nasdaq: NKTR - News) announced today that it has ceased all negotiations with potential partners for its inhaled insulin programs as a result of new data analysis from ongoing clinical trials conducted by Pfizer Inc. An increase in the number of new cases of lung cancer was observed in inhaled insulin patients as compared to the control group. All new incidences of lung cancer were in patients that are former smokers.
"The concern over this new data analysis from ongoing clinical trials has resulted in the termination of all negotiations with potential partners," said Howard W. Robin, President and CEO of Nektar. "Fortunately, over the past year Nektar has significantly transformed its business, moving away from inhaled insulin. We have made great progress expanding our research efforts and have built a deep pipeline of novel partnered and proprietary drugs in various stages of development."
Nektar will cease all spending associated with its inhaled insulin programs and will not incur any additional charges related to this event.
The Exubera label was updated by Pfizer to contain the following safety information warning:
"In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 patient-years of study drug exposure was 0.13 (5 cases over 3900 patient-years) for Exubera-treated patients and 0.02 (1 case over 4100 patient-years) for comparator-treated patients. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking."
O/T BSC....
Billionaire Joseph Lewis, has to be getting ready to jump out of his basement window, after buying 7% of Bear for $860.4 million in Septemeber. Hopefully, he was smart enough to liquidate his position prior to this weekend.
Dew are you or is anyone on this board selling? I know that a partnership maybe in the cards relatively shortly, however, I cannot face complete destruction of my shares so I may have to cut some of my losses soon...
TIA,
10nis
MNTA - exploding this morning... I don't see any news out. Anyone know anything?
TIA,
10nis
GTXI
Below is the PR regarding GTx's Phase III trial..
Press Release Source: GTx, Inc.
http://biz.yahoo.com/bw/080225/20080225005657.html?.v=1
GTx's Toremifene Citrate 80 mg Meets Primary and Key Endpoints in Phase III Trial in Advanced Prostate Cancer Patients on Androgen Deprivation Therapy
Monday February 25, 6:00 am ET
Results Show a 50 Percent Reduction in Incidence of Androgen Deprivation Induced Osteoporosis Related Vertebral Fractures
MEMPHIS, Tenn.--(BUSINESS WIRE)--GTx, Inc. (NASDAQ:GTXI - News) today announced Phase III clinical data for toremifene citrate 80 mg, the Company’s investigational therapy for the treatment of multiple side effects of androgen deprivation therapy (ADT) for advanced prostate cancer. Results show that toremifene citrate 80 mg reduced vertebral fractures and met other key endpoints, including bone mineral density, lipid profiles, and gynecomastia.
Based on these findings, GTx plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by the summer of 2008. In addition, GTx plans to present the full data set at an upcoming medical meeting.
“The toremifene citrate 80 mg Phase III ADT clinical trial is the first fracture prevention study in men receiving ADT for prostate cancer. The study confirms that men receiving ADT are at high risk for fractures. The rate of vertebral fracture in the placebo group in this study was about 10 times greater than that expected for men of a similar age not receiving ADT, as reported in other studies,” said Matthew R. Smith, MD, PhD, Director, Genitourinary Medical Oncology, Massachusetts General Hospital Cancer Center, Associate Professor of Medicine at Harvard Medical School, and Lead Principal Investigator of the Phase III ADT clinical trial.
“Androgen deprivation therapy is the cornerstone treatment for men with advanced prostate cancer, but has been associated with serious side effects. The results from this exciting study demonstrate that toremifene citrate 80 mg reduced fractures and other side effects in men taking ADT,” added Dr. Smith.
About the Disease
Androgen deprivation therapy is the most common treatment for advanced prostate cancer, used in approximately 800,000 men. ADT (e.g., leuprolide/triptorelin injections) is hormone therapy that works by reducing testosterone and estrogen. This may result in multiple estrogen related side effects, including bone loss and fractures, hot flashes, lipid changes and increased cardiovascular risk, and gynecomastia. Studies have shown that men on ADT are at risk for fractures, and ADT patients who develop a fracture have a 39 month shorter median survival. ADT has also been associated with increased risk of cardiovascular disease and death. There are no drugs approved by the FDA to treat multiple side effects of ADT for prostate cancer. Men with prostate cancer of a similar age who are not on ADT have a vertebral fracture rate of approximately 0.3% over two years.
About the Study
The two year double-blind, placebo-controlled study randomized 1,389 ADT patients at approximately 150 clinical sites in the United States and Mexico. The primary endpoint was new morphometric vertebral fractures read by an independent third party. Other key endpoints included bone mineral density, lipid changes, hot flashes, and gynecomastia.
Fracture endpoints
In a modified intent to treat analysis which included all patients with at least one evaluable study radiograph and a minimum of one dose of study drug or placebo, toremifene citrate 80 mg demonstrated a 50% reduction in morphometric vertebral fractures (p<0.05; 5% fracture rate in the placebo group). The estimated two year fracture rate for new morphometric vertebral fractures in the placebo group was 6.2%. In an intent to treat analysis which included all patients randomized into the trial, toremifene citrate 80 mg demonstrated a 53% reduction in new morphometric vertebral fractures (p=0.034; 3.6% fracture rate in the placebo group).
In prespecified subset analyses, in study patients who were greater than 80% treatment compliant, toremifene citrate 80 mg reduced vertebral morphometric fractures by 61% (p=0.017). When study patients who had greater than 7% bone loss at one year and new morphometric vertebral fractures were considered as treatment failures, toremifene citrate 80 mg compared to placebo demonstrated a 56% reduction (p=0.003).
Other key endpoints
Patients treated with toremifene citrate 80 mg compared to placebo demonstrated statistically significant increases in bone mineral density in the lumbar spine, hip, and femur skeletal sites (each site demonstrating p<0.0001). Toremifene citrate 80 mg treatment compared to placebo also resulted in a decrease in total cholesterol (p=0.011), LDL (p=0.018), and triglycerides (p<0.0001), and an increase in HDL (p=0.001). There were also statistically significant improvements in gynecomastia (p=0.003). As for the effect of toremifene citrate 80 mg on hot flashes, the evaluation of these data is still ongoing and will be reviewed with the final data set.
Safety
Toremifene citrate 80 mg had a favorable safety profile and was well tolerated. Among the most common adverse events that occurred in over 2% of study subjects were joint pain (treated 7.3%, placebo 11.8%), dizziness (treated 6.3%, placebo 5.0%), back pain (treated 5.9%, placebo 5.2%), and extremity pain (treated 5.0%, placebo 4.4%).
Venous thromboembolic events (VTE), which included both deep venous thrombosis and pulmonary embolism, were 17 (2.4 %) in the toremifene citrate 80 mg treated group and 7 (1.02 %) in the placebo group. The majority of VTEs occurred in men at high risk for a VTE including: age >80 years, history of VTE, recent surgical procedure and immobilization. In men without major risk factors for VTE, there were 3 VTE in the toremifene citrate 80 mg treated group and 2 VTE in the placebo group. The most significant VTE risk occurred in the first year of treatment. In year two, the VTE event rate in the toremifene citrate 80 mg treated group was similar to the rate observed in the placebo group.
“GTx has successfully reached an important corporate milestone event by meeting the primary and key secondary objectives of the Phase III ADT clinical trial,” said Dr. Mitchell Steiner, Chief Executive Officer of GTx. “We now can move forward with our plans to prepare and submit the NDA for toremifene citrate 80 mg.”
About GTx
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways to treat cancer, osteoporosis and bone loss, muscle wasting and other serious medical conditions.
GTx is developing ACAPODENE® (toremifene citrate), a selective estrogen receptor modulator, or SERM, in two separate clinical programs in men: first, a pivotal Phase III clinical trial evaluating toremifene citrate 80 mg for the treatment of serious side effects of androgen deprivation therapy for advanced prostate cancer, and second, a pivotal Phase III clinical trial evaluating toremifene citrate 20 mg for the prevention of prostate cancer in high risk men with high grade prostatic intraepithelial neoplasia, or PIN.
GTx licensed from Orion Corporation the rights to toremifene citrate for all indications worldwide, except breast cancer outside the United States. In 2006, GTx and Ipsen Group entered into a development and collaboration agreement for toremifene citrate in all indications except breast cancer for Europe and the Commonwealth of Independent States (CIS). Ipsen is the leading marketer of ADT (triptorelin) in Europe. Under the agreement, Ipsen will be responsible for filing for marketing approval with regulatory authorities and commercializing toremifene citrate in Europe and CIS. GTx will file for marketing approval and plans to commercialize toremifene citrate 80 mg in the United States.
GTx has formed a strategic collaboration with Merck & Co., Inc. for the development and global commercialization of selective androgen receptor modulators, or SARMs, a new class of drugs with the potential to treat a variety of indications associated with muscle wasting and bone loss, including frailty or sarcopenia, muscle wasting associated with chronic diseases, osteoporosis, and cancer cachexia. GTx also has announced that it is developing its preclinical compounds, GTx-758, an oral LH inhibitor for advanced prostate cancer, and GTx-878, an estrogen receptor beta agonist for the treatment of benign prostatic hyperplasia and chronic prostatitis.
Deals/partnerships are made every day, so why is GTC and any potential partner not close enough to agree on a deal? One would think they could structure a deal to meet somewhere in the middle (i.e., more upfront money, a lower royalty percentage but receive higher milestone payments, etc.)
Plus, most big pharma companies aren't looking to completely screw over a future partner - so I hope GTC isn't over playing their cards.
10nis
Dew - Do you plan on selling any shares any where near current levels?
TIA,
10nis
You're wrong Keitern... Had GTC obtained an advisor (Goldman, etc.) and sold the Company it would have gotten at least $2 share. By selling more and more of yourself you have to sell shares below the existing intrinsic value of the Company because you're diluting that existing base.
Time for Management to hire an advisor.
10nis
You've got that right... Its time for Management to put GTC up for sale to the highest bidder.
Dew - Can you throw around your weight some and urge Management to stop diluting shareholders because otherwise we will all be holding just a ton of wallpaper...
10nis
O/T - Stimulus package....
I don't understand why its so hard to hand out money? Give every single person X dollars no matter rich or poor. However, they should hand it out via Federal Government Gift Card that you have to go pick up at your local mall or WalMart, etc. This would force people to have to buy something with it vs. putting it in the bank and how many rich folk would drive to their local WalMart to wait in-line with the less fortunate? I would assume not too many. Anyways, just my two cents.
Have a great day,
10nis
O/T....
Is Scottrade down for anyone else? I can log into my account however it says "Account Information and Trading is not available at this time. Please contact your local branch to place trades or to verify open orders and executions."
Anyone else having the same problem?
Thanks,
10nis
No late Friday night news... So, good top-line data should be announced either Monday or Tuesday morning, IMO. I'm still expecting some positive movement in the stock price on good news (as top-line data risk is removed). If we can break above the 52-week high, GTC could trade substantially higher as new investors/traders move into it hand over fist.
IMO, if a partnership is not announced with or within two months of the top-line data, GTC will put itself up for sale through a non-disclosed bid/auction process with a minimum expected offer of $3-4/share. Just seems like the only way management can play their cards to maximize shareholder value. All of this is JMHO which usually doesn't mean much.
Have a great weekend,
10nis
croumagnon...
Can you seriously post something worth reading? All you talk about is share price manipulation, blah, blah, blah... Either hold your shares and live with the outcome or sell and move on. Thanks.
Hope everyone had a great weekend,
10nis
Does anyone follow CRME? Just curious on people's thoughts on FDA approval and long-term value.
Thanks,
10nis
Ahead of the Bell: Cardiome FDA Decision
Friday January 18, 5:58 am ET
FDA to Decide on Cardiome and Astellas Drug to Treat Irregular Heart Rhythms
WASHINGTON (AP) -- Canadian drug maker Cardiome Pharma is expected to learn as early as Friday whether its drug to treat irregular heart rhythms can be marketed in the U.S.
The Food and Drug Administration's decision on Cardiome's drug is likely before the weekend because the company filed the application 10 months ago as of Jan. 19. Generally, the FDA makes drug approval decisions within 10 months.
The FDA's approval is critical for Cardiome, which has no products on the U.S. market. Cardiome's drug, vernakalant, treats atrial fibrillation, a condition that causes the heart's upper chambers to contract randomly. Left untreated, the condition can lead to heart damage.
At an FDA meeting last month, a panel of outside experts voted 6-2 in favor of approval of vernakalant. While the agency often follows the panel's recommendations, it is not required to do so.
Cardiome developed vernakalant in cooperation with Japanese drug maker Astellas Pharma, which funded 75 percent of the research costs. Under a 2003 agreement, the two companies will cooperatively market the injectable version of the drug in the U.S.
A pill version of the drug is currently in mid-stage trials, and, if approved, would be marketed exclusively by Cardiome.
The company's other potential drugs are still in the early testing stages.
<<vinman I don't know what GTCB will do in the long term. In the long term we are all dead. All I know is that right now it is not to be touched and the stock continues to go lower. I like stocks that move higher, not lower.>>
I think everyone likes stocks that move higher vs. lower over time. However, if you're an investor you like to buy on the way down and you prefer to buy as much as you can as cheaply as you can before selling to people like you (sillybeaver) who like to buy high and sell even higher (cramerlike). To each their own, but IMO today's trading was solely based on insignificant news of a potential delisting. If GTC is delisted it doesn't make Atryn and related IP worth any less than its worth today. So, if you believe in GTC and its future you should be buying hand over fist today.
Any guesses on when top-line data will be released - next week or the last week of January?
10nis
As you requested.... VRUS PR. Happy New Year!!
Press Release Source: Pharmasset, Inc.
http://biz.yahoo.com/prnews/071231/clm003.html?.v=101
Pharmasset Reports Fiscal Year End 2007 Financial Results
Monday December 31, 4:43 pm ET
PRINCETON, N.J., Dec. 31 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News), a clinical stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections, reported audited financial results for the fiscal year ended September 30, 2007. Pharmasset reported a net loss attributable to common stockholders of $6.8 million, or $0.46 per share, as compared to a net loss attributable to common stockholders of $12.4 million, or $1.19 per share for the same period in 2006.
Revenues were $22.0 million during the fiscal year 2007, primarily consisting of development milestones and the amortization of payments received from Roche from the hepatitis C virus (HCV) collaboration agreement that were previously recorded as deferred revenue. Revenues for the same period in 2006 were $5.4 million. This $16.6 million increase from the year ago period was primarily due to the receipt of milestone payments from Roche totaling $20.0 million during fiscal year 2007. Investment income was $2.5 million during fiscal year 2007 compared to $1.7 million during fiscal year 2006. This $0.8 million increase was due to higher average invested cash balances during 2007.
Total costs and expenses for the fiscal year ended September 30, 2007 were $29.5 million as compared to $18.4 million for the same period in 2006. The increased operating expenses for fiscal year 2007 were primarily the result of an increase in Phase 3 registration clinical trial expenses for clevudine for the treatment of chronic hepatitis B virus (HBV) infection, as well as drug discovery, non-cash stock compensation and depreciation expenses.
At September 30, 2007, Pharmasset held $68.7 million in cash and cash equivalents and approximately $1.3 million of short-term investments. In September 2007, Pharmasset entered into a $30 million working capital loan agreement, of which $10 million was funded in October 2007.
"Pharmasset achieved significant clinical development and financial progress in 2007," stated Schaefer Price, Pharmasset's President & CEO. "We remain focused on building our hepatitis and HIV franchises with novel drug candidates that could significantly improve therapeutic standards of care. We hope to maintain the momentum in 2008 by completing HBV patient enrollment of the clevudine Phase 3 clinical trials for registration in the Americas and Europe. In addition, since the first two cohorts were fully enrolled earlier this month, we plan to report preliminary safety and efficacy data following 4 weeks of combination therapy with R7128 and Pegasys® plus Copegus® in the first calendar quarter of 2008."
Fiscal Year 2007 Highlights
-- Initiated HBV patient dosing of clevudine Phase 3 clinical trials for
registration in the Americas and Europe.
-- Reported clevudine's approval for the treatment of HBV in South Korea.
Clevudine is marketed by Bukwang Pharmaceuticals in South Korea under
the brand name Levovir.
-- Completed Phase 1 single and multiple ascending dose studies of R7128
in both healthy volunteers and patients chronically infected with HCV.
R7128 was generally safe and well tolerated and demonstrated potent,
dose-dependent antiviral activity in these studies.
-- Discovered a new series of proprietary uridine phosphoramidates that
have demonstrated potent anti-HCV activity. We are evaluating these
molecules for potential advancement toward future development.
-- Confirmed Racivir's antiviral activity in treatment-experienced HIV
patients who were failing their HIV treatment regimen and had HIV with
the M184V resistance mutation.
-- Continued building our antiviral clinical development team by adding
experienced senior leadership, including Dr. Michelle Berrey, Chief
Medical Officer and Dr. Michael Rogers, Chief Development Officer.
-- Completed an initial public offering (IPO) of 5,050,000 shares of
common stock at a price of $9.00 per share and began trading on the
NASDAQ Global Market under the symbol "VRUS." Net cash proceeds from
the IPO were $40.7 million.
-- Earned $20.0 million in milestone payments from Roche as part of a
collaboration for the development of R7128 for the treatment of chronic
HCV infection.
-- Closed a $30 million working capital loan agreement.
Calendar Year 2008 Anticipated Milestones
-- Release preliminary safety and efficacy data from a Phase 1, Part 3
multiple ascending dose study of R7128 following 4 weeks of combination
therapy with Pegasys plus Copegus in the first calendar quarter of
2008.
-- Report final safety and efficacy data from a Phase 1, Part 3 multiple
ascending dose study of R7128 following 4 weeks of combination therapy
with Pegasys plus Copegus in the second calendar quarter of 2008.
-- Complete patient enrollment for clevudine Phase 3 registration clinical
trials in the second calendar half of 2008.
-- Initiate a Phase 2b combination study of R7128 with Pegasys plus
Copegus in the second calendar half of 2008, assuming the successful
completion of the on-going R7128 Phase 1 study and the timely
completion of all required Phase 2b study preparation activities.
About Pharmasset
Pharmasset is a clinical stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Pharmasset is currently developing three product candidates. Clevudine, for the treatment of chronic HBV infection, is enrolling Phase 3 clinical trials for registration in North, Central and South America and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals in South Korea under the brand name Levovir. R7128, an orally administered treatment for chronic HCV infection, is in a 4-week Phase 1 clinical trial in combination with Pegasys® and Copegus® through a strategic collaboration with Roche. Racivir, which is being developed for the treatment of HIV in combination with other approved HIV drugs, has completed a Phase 2 clinical trial.
Contact
Alan Roemer, Vice President
Investor Relations & Corporate Communications
alan.roemer@pharmasset.com
Office: (609) 613-4125
Forward-Looking Statements
Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are "forward-looking statements" that involve risks and uncertainties, including without limitation the risk that adverse events could cause the cessation of the Phase 3 registration studies and/or our development of clevudine, the risk that adverse events could cause the cessation of the Phase 1 combination study and/or our development of R7128, including the risk that we will fail to release preliminary or final safety and efficacy data from a Phase 1, Part 3 multiple ascending dose study and the risk that we will fail to initiate a Phase 2b combination study of R7128 with Pegasys plus Copegus in the second calendar half of 2008, the risk that our collaboration with Roche will not continue or will not be successful and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section of our Annual Report on Form 10-K for the fiscal year ended September 30, 2007 filed with the Securities and Exchange Commission entitled "Risk Factors" and discussions of potential risks and uncertainties in our subsequent filings with the Securities and Exchange Commission.
PHARMASSET, INC.
STATEMENTS OF OPERATIONS AND COMPREHENSIVE NET LOSS
Years Ended Nine Months
September 30, Ended
------------------------- September 30,
2007 2006 2005
------------------------- -------------
REVENUES $22,009,458 $5,424,614 $3,719,104
------------------------- -------------
COSTS AND EXPENSES:
Research and development 20,318,910 10,497,703 10,468,026
General and administrative 9,210,623 7,911,545 8,095,897
------------------------- -------------
Total costs and expenses 29,529,533 18,409,248 18,563,923
------------------------- -------------
OPERATING LOSS (7,520,075) (12,984,634) (14,844,819)
INVESTMENT INCOME 2,470,563 1,658,977 1,136,035
INTEREST EXPENSE (15,136) - -
------------------------- -------------
LOSS BEFORE INCOME TAXES (5,064,648) (11,325,657) (13,708,784)
PROVISION FOR INCOME TAXES - - -
------------------------- -------------
NET LOSS (5,064,648) (11,325,657) (13,708,784)
REDEEMABLE PREFERRED STOCK
ACCRETION 1,775,684 1,110,973 2,286,799
------------------------- -------------
NET LOSS ATTRIBUTABLE TO
COMMON STOCKHOLDERS $(6,840,332) $(12,436,630) $(15,995,583)
========================== =============
COMPREHENSIVE NET LOSS:
NET LOSS $(5,064,648) $(11,325,657) $(13,708,784)
UNREALIZED GAIN (LOSS) ON
AVAILABLE-FOR-SALE
INVESTMENTS 2,100 (56,465) 58,454
------------------------- -------------
COMPREHENSIVE NET LOSS: $(5,062,548) $(11,382,122) $(13,650,330)
========================== =============
NET LOSS ATTRIBUTABLE TO
COMMON
STOCKHOLDERS PER SHARE:
BASIC $(0.46) $(1.19) $(2.42)
DILUTED $(0.46) $(1.19) $(2.42)
WEIGHTED AVERAGE SHARES
OUTSTANDING:
BASIC 14,990,472 10,462,369 6,630,463
DILUTED 14,990,472 10,462,369 6,630,463
PHARMASSET, INC.
BALANCE SHEETS
As of September 30,
----------------------------
2007 2006
----------------------------
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $68,745,694 $26,182,316
Short-term investments 1,252,113 1,250,013
Amounts due under collaborative
agreements 919,110 297,070
Prepaid expenses and other assets 783,311 359,082
Deferred offering costs - 1,608,826
----------------------------
Total current assets 71,700,228 29,697,307
----------------------------
EQUIPMENT AND LEASEHOLD IMPROVEMENTS:
Laboratory, office furniture and
equipment 2,462,647 1,877,095
Leasehold improvements 1,836,553 1,836,553
----------------------------
4,299,200 3,713,648
Less accumulated depreciation and
amortization (1,437,080) (544,725)
----------------------------
Total equipment and leasehold
improvements, net 2,862,120 3,168,923
OTHER ASSETS 1,282,051 131,300
----------------------------
TOTAL $75,844,399 $32,997,530
============================
LIABILITIES, REDEEMABLE STOCK AND WARRANTS,
AND STOCKHOLDERS' EQUITY (DEFICIT)
CURRENT LIABILITIES:
Accounts payable $3,281,600 $710,386
Accrued expenses 5,513,407 2,055,025
Deferred rent 124,462 124,462
Current portion of capital lease
obligation 159,440 -
Deferred revenue 1,857,136 1,803,564
----------------------------
Total current liabilities 10,936,045 4,693,437
DEFERRED RENT 204,256 328,718
NON CURRENT PORTION OF CAPITAL LEASE
OBLIGATION 41,641 -
DEFERRED REVENUE 5,726,131 7,364,547
----------------------------
Total liabilities 16,908,073 12,386,702
----------------------------
COMMITMENTS
REDEEMABLE STOCK AND WARRANTS
Series B, C, D, and R redeemable
convertible stock - 19,376,679
Series R-1 warrants - 264,000
Redeemable common stock - 1,190,251
Total redeemable stock and
warrants ----------------------------
- 20,830,930
----------------------------
STOCKHOLDER'S EQUITY (DEFICIT)
Series A convertible preferred stock - 2,640
Series D-1 warrants - 5,411,932
Common Stock, $0.001 par value,
21,232,991 and 10,291,386 shares
outstanding at September 30, 2007
and 2006, respectively 21,233 10,291
Warrants to purchase 66,390 shares
of common stock 526,720 -
Additional paid-in capital 115,518,201 44,480,015
Accumulated other comprehensive
income 4,405 2,305
Accumulated deficit (57,134,233) (50,127,285)
----------------------------
Total stockholders' equity
(deficit) 58,936,326 (220,102)
----------------------------
TOTAL $75,844,399 $32,997,530
============================
--------------------------------------------------------------------------------
Source: Pharmasset, Inc.
No more insider buys until the top-line data is released which per Dew could come at any time in January. Let's hope we get some very good news later this week or next week.
10nis
Top-line data...
What is the earliest (day) GTC can announce the top-line data in 2008 as a result of the insider buying?
Thanks,
10nis
Probably not a golden drug....
http://biz.yahoo.com/prnews/071226/nyw020.html?.v=101