Marucci had better do something. He owes the shareholders a much higher valuation and he owes the buyers of the secondary offering one year ago a much higher valuation. He'd better be holding a nut flush as we head into the week of SNO and ReACT. There hasn't been much good news at all for CLDX investors this year, not since the secondary offering in fact. The fact is that if Rindo cannot be commercialized in 2015 or very early 2016 then the company will need money, and that will weigh on the share price until it gets resolved.
Do you foresee an early stop in ACT IV due to efficacy, permitting an NDA for Rindo in December 2015?
Thanks for that explanation. Still worried about this change in the trial, though.
Notable changes that I noticed:
Enrollment completion date was in 2015, now November 2016.
Study completion date was in 2016, now November 2018.
It was already announced that the primary outcome measure would be PFS instead of ORR.
The following enrollment criterion was removed: "Breast cancer must be resistant or intolerant to treatment containing taxane (e.g. Taxol)."
The biggest problem I have with the change in protocol is that it pushes study completion out to November 2018 whereas when the trial was initiated it was expected that the final data readout would be had in 2016. So that is a TWO YEAR DELAY in results. Celldex will have run out of money by then, and Glemba will not be available for commercialization or revenue.
It is up to ReACT data to save the company's finances.
I wan to know more about what AM was thinking when this change was made and why it was announced prior to ReACT when it had to have been known that announcing it without a CC to explain it would make the market nervous. Now we learn the trial has been extended out for four years from today. What is up?
The only near-term revenue generator for Celldex is Rindo. Glemba and Varli won't be ready until 2018, at least. Celldex may have money for two years, but it doesn't look good after that.
Buyout is looking more and more attractive and, regrettably, more necessary.
Haven't studied them yet, just noticed them. Thought I'd post for others to take a look also. I'm going back there now to read the changes carefully.
That cohort is designed to trigger full enrollment if evidence of anti-tumor activity is found in the first 23 patients. The decision to go ahead with full enrollment, or not to, has not been announced. Perhaps the company is waiting for ReACT data to be disclosed and at the CC on the 14th it will discuss future enrollment plans.
It's difficult to see how Varli is going to support an increased share price unless it comes in the form of a buyout of Celldex for the Varli asset.
There is a new combination Varli trial listed on the clinicaltrials website, not yet recruiting, that will last until March 2017. That's too far in the future to be able to have an impact on the share price .Worse, it's after Celldex runs out of money. With METRIC enrollment postponed Glemba won't be commercialized by 2016. If all the Varli combos that are yet to be listed also take two years or more to complete, how will any news about Varli except a buyout cause the share price to increase?
The only thing it seems that shareholders and management can rely on in the near term is an early approval of Rindo in 2015, based largely on strong ReACT data.
Varli seems promising and valuable, but it's value cannot be realized much at the present time unless another company buys Celldex in order to acquire Varli.
One could also be cynical about the timing of the announcement of the change in the METRIC protocol. One could ask whether management has colluded with certain institutions to release the news when it did, in the manner it did, in order to create just the sort of selloff in the stock that occurred, allowing those institutions to cover their short positions or accumulate more shares ahead of the presentation of ReACT data and, if you subscribe to the theory, ahead of the buyout.
Are you hypothesizing that the revision to the METRIC protocol was decided upon by management in part because the delay in final enrollment would be inconsequential from a financial standpoint on account of evidence management has from ReACT that is virtually certain to support early approval and commercialization of Rindo in 2015, hence providing a revenue stream that would offset any financial consequences of delaying METRIC's patient accrual and completion?
It's related to the shares given to BIOSYN as part of their compensation for the KLH supply contract entered into last month. All it does is register half of the shares given to BIOSYN for sale. BIOSYN may sell those shares, or not, depending on what it wants to do.
Not yet recruiting, scheduled to begin in December.
Purpose: "This study evaluates the combination of stereotactic body radiation therapy (SBRT) and CDX-1127 in subjects with castration resistant prostate cancer. Subjects will be randomized to one of three arms to receive SBRT prior to, after, or in conjunction with the first dose of CDX-1127."
Go to the clinicaltrials site to read more about it. The study isn't expected to be concluded until March 2017 -- yeah, that is not a typo: March 2017. If the Varli combination trials are going to last until 2017, then Celldex is going to have to raise money by 2016 if Rindo is not commercialized by then.
But how can the company raise money based on Varli efficacy if the Varli data won't be known at the time partnerships are discussed or -- forbid -- another secondary is offered?
I hope all or most of the Varli trials will not last until 2017.
More reason, I suppose, to hope that ReACT will save the company from having to do further financing.
Nothing is guaranteed, of course, but I believe this is a handy summary of the reasons longs believe that the ReACT data presented on the 14th are going to be highly positive:
1) Marucci has been building a sales and marketing team for Rindo and discussing those preparations openly and enthusiastically at CCs this year. Why prepare in 2014 if launch not expected until 2017?
2) Two presentations on Rindo at SNO: ReACT and compassionate use, followed by Dr. Michael Weller, world renowned expert on GBM, discussing new GBM immunotherapy.
3) Special SNO journal supplement with an article on EGFRviii+ GBM by Dr. John Sampson, one of the creators of Rindo. A second article by Dr. Weller (see #2) about treating GBM.
4) Celldex will have a booth at SNO and is a Platinum Sponsor. Why spend the money for that if ReACT will be mediocre? Marucci wants a strong, prominent presence at the conference.
5) Signing a KLH (ingredient in Rindo) supply contract with BIOSYN in October that expires in 2029. Why such a long contract term if Rindo is not expected to be commercialized? Also BIOSYN accepting CLDX stock in partial payment for the contract, with 50% of shares locked up for one year. Why would BiOSYN agree to that unless it believed based on Celldex's KLH supply needs that CLDX stock will be significantly higher in one year from Rindo sales that might commence over the next year?
6) Summer promotions of Tom Davis and Tibor Keler to Executive VPs. Both men were instrumental in advancing Rindo from its beginnings to the current stage. Why promote them unless Rindo has shown clear signs of being ready for commercialization? Why promote them if disappointing news about Rindo is on the horizon?
7) Slide 9 in the Q2 CC presentation on August 6, 2014, which presented very strong evidence that doctors would prescribe Rindo for their EGFRviii GBM patients. Why conduct a global marketing survey unless you are confident that you are close to product launch?
That's all I can remember.
Yes, all signs such as you point out -- being a platinum sponsor of SNO -- indicate the Rindo data will be highly positive. Too bad the negative METRIC news had to come at this time.
You are correct. Varli does make the company valuable, however that value is difficult to realize at present because it is not marketable and merely beginning phase 2 studies. Perhaps AM should consider a partnership in Varli. Had METRIC gone well and had ACT IV enrollment not been delayed, that might not have been necessary, but AM now has to determine how he will raise money before he runs out in 2016. Partnering Varli is an option.
Or just sell the company, in which case all of AM's options become fully vested.
Yes, I believe you are correct: the conference presentations occur on Friday afternoon. Celldex management couldn't host the CC in the morning because that would upstage the SNO conference. The soonest management could host a CC is Friday afternoon, after the data are presented at SNO. In this case, the Friday after market close timing of the CC is not a bad omen.
Thanks for the reassurance. A 21% drop is hard to take in one day. I didn't take anything you said as condescending in the least.
I'm wondering how much longer until the climactic scene in the script gets played out.
I hope you're right, fug. How confident are you? I would welcome the company's sale at this point. How soon after ReACT would it be announced, and does the METRIC setback and price drop today change anything important?
Not having a CC was inexcusable UNLESS (as I have said) Marucci knows he's got ReACT data that will entirely compensate for yesterday's surprise bad news and then some. If the ReACT data are adequate to support early approval of Rindo, the market will forget all about METRIC and CLDX will double in share price overnight. Maybe Marucci is banking on that. There have been quite a few tells that the ReACT data are going to be good, but we don't know how good.
It's up to ReACT to save the company and to save Marucci's credibility as CEO.
Then you've got fugkyouhonkey's theory that the company has been sold already for between $50 and $60, so what does Marucci care about an event like today's dump if that's the case? No CC necessary.
May 1, 1Q earnings PR: Marucci said, "We... are making excellent progress with our accelerated approval study of glembatumumab vedotin in triple negative breast cancer with more than 50 sites now open to screen patients."
Nov 3, 3Q earnings PR: Marucci said, "...in an effort to increase enrollment, we have implemented a protocol amendment to expand entry criteria. We believe this change provides advantages to the glemba program, including the opportunity to potentially file for full approval across a broader subset of patients in both the US and the EU."
In barely six months we went from making "excellent progress" to a trial protocol change "in an effort to increase enrollment."
Can the man be trusted?
It's up to ReACT data on the 14th to save the company and to save Marucci's credibility as a CEO.
Just for fun, let's look at what Marucci said about ReACT on May 29, 2013 at the Deutsche Bank Health Care Conference:
"So this is the first study where patients in the recurrent setting will have seen rindo. So these are the first patients that we will have that are vIII positive patients. We don't have any data on these vIII patients with Avastin. And so expectations when we started up this study was to look at these two groups and in the refractory setting historically there's been a response rate of less than 5% PFS in the two to three months range and survival in the three to four months range. These patients just -- the disease is so aggressive that they just don't survive that long.
In the group 1 setting where we are testing it in combination with Avastin, that as you know was approved in frontline metastatic with a 28% response rate of 4.2 months PFS and the nine month survival but again we don't know how the vIII patients do on that study. So those will be important datasets for us. If we can certainly improve in the recurrent setting, or improve upon the group 1, I think that will be extremely positive."
It's up to ReACT to save the company.
"You're" really childish sometimes. Not every instance of deception is legally actionable, nor is every instance of deception overt. What is emerging is a pattern on the part of Marucci in painting a rosier picture than is warranted then surprising the market with bad news. Exhibit "A": CDX-1135; exhibit "B": METRIC.
Interesting too that in both cases the bad news was delayed until after Marucci issued new shares. In the case of CDX-1135, it was after the secondary offering. In the case of METRIC, it was after issuing new shares to BIOSYN as part of compensation for a KLH supply contract. I wonder whether BIOSYN still believes CLDX is as good an investment as it thought when it made the agreement, before the surprise bad news about METRIC.
Now we'll see on the 14th whether Marucci has been painting a rosier picture than is warranted about ReACT and Rindo. What is the purpose of having a sales team in place and boasting that you will be ready to hit the ground running after Rindo approval if that's not going to happen until 2017?