Is he in this for the long haul or is it something else?
Does he plan to take some level of control over the company by at least getting some members on the board?
Does he want to take control and put the company up for sale to the best bidder for CYC065 interests?
Certainly he isn't betting on anything good coming out of the SEAMLESS clinical trial.
sapacitibine has decent longer term data and gets European approval. I know that the market and share price says absolutely no but you never know.
After ours up over $1 billion in market capitalization based on phase 1 data on less than 50 patients. Well I certainly hope that the market will wake up to Cyclacel's CDK program and give it some value less than a negative number.
Iceman you are wrong about me being the L2L poster because I am not. I am no fan of Spiro but I also very much doubt there was ever any decent licesning deal on the table. Why not? Because of the long history of drug development failures in AML. BP knows this and probably wasn't going to offer Spiro a single red cent until he at least passed futility. I think Spiro thought he had a high probability of success in passing futility. Now are you going to tell me that you blame Spiro for an unexpectedly high early death rate? The DACO-016 trial had a mOs of 6.7 months and in SEAMLESS there was a 70% death rate across both arms after 6 months. I wouldn't blame that on sapa not working but just an unforeseen complication of running clinical trials on a elderly population with a very high early mortality rate regardless of what is given.
As for this latest dilution at $1...... We do not know what the motivation was because Spiro didn't need the extra $10M in cash for at least another year. I suspect he just wanted to give himself an additional financial cushion so he could continue drug development without having to worry about the cash running low before his contract expires and he was probably offered this deal rather than seeking it. No coincidence that Dart was doubling down under $1 after the futility news and again doubled down again with the placement. I believe Dart is now viewing his investment longer term and might be interested in CYC065 development because there could be a very huge longer term payoff in several years. There is little doubt in my mind that as more information and data is generated on the CDK2/4 drugs for breast cancer that BP will take a serious look at 065. If the company decides to run the trial on Herceptin refractory breast cancer and shows no signs of serious adverse events and an actual clinical benefit then investors will view CYCC much differently.
Ice you are full of yourself. If you know so much why did you buy high and sell low? Spiro may have had an offer that was not good enough in his opinion and was overly confident that SEAMLESS would pass futility allowing him to wait for a better offer? Since nobody knows for sure nobody can make a criticism of Spiro's performance concerning potential partnering. You're such a know-it-all. If CYC065 passes muster in p1 trials they could be bought out for a couple hundred million and you will have lost money for your impatience.
I think the reason for a lack of a run up was because after seeing other small companies fail in both AML and MDS, many thought sapa would see the same fate. This includes SNSS and ONTX that did a huge secondary at $15 before they came out with their 300 patient p3 MDS clinical trial that failed. Stock is now in the $2s. Those investors lost far more than any of the monies invested in CYCC at $3 or $3.50.
It is easy to second guess after the fact. Does anyone know for a fact if Spiro had any solid offers on the table? Had he taken a low ball offer and SEAMLESS passed futility then everyone would be saying he took too little. Spiro took all the risks and had SEAMLESS passed futility he would have taken all of the reward for himself and the share holders and everyone would be praising him. This is part of the the gamble in biotechs. The other thing to note is that the market has priced SEAMLESS as a complete failure so if the experimental arm shows a benefit over the control arm from 6 to 12 months, then there still is a chance of EU approval considering the lack of alternatives and that an oral drug would save five bimonthly visits to the hospital for IV decitibine where quality of life time and exposure to infections will be important secondary considerations.
I don' know what the KOLs told him regarding sapacitibine in refractory MDS, but when you have some phase 2 data showing a 10 month survival time at the two higher doses vs about a 5 to 6 month BSC survival, you don't start attempting a new science experiment by alternating with low dose cytarabine. They should do a blinded study with placebo capsule and BSC vs sapacitibine and BSC and let the cards fall where they may,
Although small its a start. This guy is a real mover and shaker. If you want to se how much influence he has had on biotech companies check out the info monkey article on the ARIA news for Yahoo. He has ousted CEOs of large biotech companies and has been involved in investor activist moves such as gaining BOD seats in no less than 5 biotechs. Hopefully he will increase his position substantially and then attempt to initiate some changes at Cyclacel. Although Dart is the largest holder I doubt he will do any activist moves. Spiro really needs to go. He is more of a liability than an asset to the CYCC investors. Guy has made millions in salary over the years and has produced virtually nothing via deals and has consistently destroyed share holder value.
Expect CYCC related data on CYC065, sapacitibine and seliciclib
Some abstract titles on 065
Cyclin E amplification predicts sensitivity of primary Uterine Serous Carcinoma (USC) cell lines to the cdk2 inhibitor CYC065
CYC065, a novel CDK2/5/9 inhibitor: detailed mechanistic studies, determinants of sensitivity and synergistic combinations
has absolutely no reflection of pipeline potential/value. For instance, if we look at 2012 gaining approval, Fusilev sales at that point will be a non factor. In the mean time current Fusilev sales and the rest of the approved drugs simply pays for the salesforce and the R&D for the pipeline and worse case scenario is that a generic Fusilev gets approval failing appeal in 18 months and then can only be manufactured and sold for pediatric osteosarcoma. Raj claims that colon cancer indication accounts for 99.9% of their sales. In other words, al this hoopla regarding the Fusilev patent case will have no effect on the income stream for at least 18 months and then only if the manufacturer decides to produce it for a small indicaiton that would actually most likely be a money losing indication. Listened to Raj's presentation last night. My 2012 question was answered. Estmates 2 years for p3 2012 trial completion. By then Amgen drug goes generic so if 2012 gets approved it will be competitively priced and probably will do at least $500M and maybe reach BB status. I wouldn't be surprised if Amgen buys them out before hand. Always a good thing to own your competition. All those complaining about how rich Raj has become on this company is silly. It is like complaining that Bill Gates got too rich on the company he started from scratch. Spectrum is Raj's baby and he will continue to get rich on it as always regardless of how this stock trades. Ultimately its going to be about the pipeline. I noticed Raj referring to some other drugs in the pipeline that could be blockbusters. What are those drugs? I didn't know there was more than 2012 that had that potential.
Yes, I noticed that too. Now that Panobinostat officially gains FDA approval in multiple myeloma, won't surprise me if Novartis plays the label expansion game by buying CYCC and running clinical trials with Panobinostat/sapacitibine in AML. Ewald has ties to both Novartis and MD Anderson. I also think Novartis would be interested in taking a lead role in CDK2/9 development on top of their 4/6 program and they can do it by buying Cyclacel.
If I were an institution who knows the story and was sitting on the sidelines, I certainly would strongly consider a newly established position if I could buy shares in volumer under $6. It would be an "investment" looking forwards 2 years primarily based on SPI-2012's potential. Fusilev is only important for the next year or two.. I would very much doubt that generic sales would be hurt so bad that they would have to issue new stock which is what the short thesis claims. I completely disagree with Spectrum having to issue stock. That is where the shorts would be covering ie hedge fund shorting their own shares and covering on by buying in on a placement and cashing in on the short end of the hedge without getting caught in a squeeze. If they can't do that they will eventually get squeezed because I don't see any bad news on the horizon othr than questionable Fusilev sales over the next year based upon generic competition.
What kind of timeline are we talking? This is not a cancer drug. Cancer drug trials often drag on for years. This is a drug to fight the side effects of chemotherapy by stimulating neutrophils that are so often repressed in chemo Tx. My understanding is that it is a multibillion dollar sector with only 2 competitors. If 2012 gains approval we are talking income levels that could reach $1B. Even $500M puts the stock way above current valuations.
Well, I remember Raj's "the best is yet to come" statement before the gap down on Fusilev sales. I think everyone expected it to happen but not as abruptly as it did. We can also quote Raj as saying that the Fusilev patents were "rock solid". What was rock solid was the Orphan indication for colorectal cancer indication. I believe that a generic Fusilev with label indication for osteosarcoma is going to have difficulty penetrating much into Fusilev sales. I even question if they will end up manufacturing and distributing the drug as I believe there will be no profit in it for them until the colorectal indication expires in 2019. By then a lot will have changed. Their biggest costs are paying for a sales force. Any new drug added to the bag makes a huge difference and that is why shorter term CE Melaphan will be an important driver but the big score will an approvable 2012. If 2012 gains approval we could be talking a +$50 plus stock. Does anybody know how long the phase 3 SPI-2012 clinical trials will take? My understanding is that the actual trial time is relatively short so the majority of time lag will be involved in enrollment but once fully enrolled it will be a short trial.
Sagent starts manufacturing Fusilev generic. They can only label and market and sell it for osteosarcoma indication. FUSILEV sales take a small hit......eventually 10 to 15%.. Sooner or later this stock becomes about focus on the pipeline prospects rather than FUSILEV sales. Raj got lucky with Fusilev in that he paid peanuts for it and ended up having sales in excess of $500M and counting. It allowed him to build his little empire and buy a few more drugs and now he has a steady product income stream that helps support the pipeline. The future of SPPI is the pipeline and not Fusilev sales although the hedge funds continue playing the Fusilev card. Once CE Melphalan gains approval and starts to generate income Fusilev sales will matter even less. The big prizes IMO are in APAZIQUONE to treat non-muscle invasive bladder cancer; and SPI-2012 for the treatment of chemotherapy-induced neutropenia. If but one of these drugs sees approval in the coming years nobody will be debating if the company will tradie at $5 or $7. It will be more like $25 to $30. Unless you are sitting on margin, it doesn't matter if the hedgies jerk the stock around tomorrow morning. They have a lot of shares to cover and it sounds like many will take an advantage of any decent buying opportunities. So after after any downward swings tomorrow morning, when will be the next decent covering opportunity for the shorts?
What about the patent on the manufacturing process?
Can the generic be produced in a cost efficient manner by Sandoz to get equivalent yields using another manufacturing process?
My understanding from what I read here is that Spectrum has a patent protecting how the drug is manufactured. Is this going to be another stumbling block/barrier for a generic entry or does Sandoz have an alternative cost effective manufacturing process?
If what you say is true and best case scenario for Sandoz is a approval of a generic Fusilev label restricted to the osteosacrcoma indication, it would appear to me that if we consider manufacturing/handling/marketing costs, it would not be economically feasible for the company to proceed with the manufacturing/sales unless they think they can bypass the Orphan Status by getting doctors to use the drug extralabel for the colorectal cancer indication. The next question would be the attitude of the insurance companies. If they know an identical cheaper generic product is available for extra label use, can they deny Fusilev coverage by saying there is a cheaper generic equivalent regardless if carries label approval for colorectal cancer?
Seems to me that there are a lot of issues here that need more clarity. I am assuming the company will spend this weekend deciding on exactly just how to respond to this court verdict if at all unless there is an immediate threat that a Fusilev generic is going to me manufactured/sold within the next 6 to 12 months.
FWIW, I think the PPS has been completely controlled by hedge funds and options and the convert loan interest and not by anything rational such as approved product sales plus pipeline value. Other biotech stocks trade with billion plus market caps with no approved drugs based upon speculative potential of pipeline alone.
Bears saying they can manufacture and sell the drug immediately.
Bulls saying that there are other court decisions and patent issues yet to be resolved and even more delay with an appeal process. Bulls mentioning the Orphan Status Until 2018. My understanding is that a Sandoz copy cat would not be able to gain FDA approval if Spectrum has an Orphan status. Nothing gets approved/manufactured/labeled and sold without FDA approval. So how does Sandoz get around getting approval if Fusilev has Orphan Status? My understanding is that Orphan status means market exclusivity until the status expires?
Can anyone give me any links to exclusivity protection in regards to FDA Orphan Status?
I hope you are right. SPPI can be a $30 stock easy if Apaz gets approved, the courts find in favor of SPPI in the Fusilev patent case and if we see more clarity on the granulocyte stimulating drug. A lot of shorts still not covering. When their hand gets forced there can be a huge upwards squeeze until the last few cents get expelled from their bank accounts.