AM wanted to keep CLDX independent, he wanted to cross the goal line himself.
That's no longer realistic. AM was too aggressive. Had things gone well, it would have been very lucrative, but things have not gone well.
There is the Hail Mary pass of ReACT, however.
Still, sale of the company now looks like the best option for AM, for CLDX, for shareholders and for the company's pipeline. A major pharma that buys CLDX would have the resources to advance the pipeline and the expertise to manage its development. AM seems not to have those abilities.
Look forward to seeing what the buyout price well be.
It's different because it's a near 20% drop in one day.
It's different because management has had to alter a trial protocol, postponing commercialization.
It's different because the stock hasn't been above $20 for over six months, and it can't support gains in the high teens.
It's different because each time we head back up it's not as high as the previous occasion.
It's different because Marucci has just about depleted investor confidence.
It's different because management is not taking questions about the trial protocol revision.
It's different because management is spending money too aggressively, and it looks like some of that money is being spent unwisely.
It's different because now investors are worried about financial solvency through to commercialization.
You people don't understand. How many of you are there? Celldex was counting on commercializing Glemba by 2016. That's out the door now.
Sure from a scientific standpoint the trial is unaffected, but from a business standpoint it's a huge blow to the company because the company needs revenue. There will be no Glemba revenue until 2018, if at all.
THe Glemba news was bad, but this is overdone.
If you don't comprehend the bad news in the Glemba trial, you're a fool. I reassess my investments based on the evidence. Yesterday's evidence was very bad. ReACT might change that, but for now things are not looking good for the company.
Because of their great contributions to the Glemba program?
If ReACT data aren't good enough for early approval for Rindo, then AM has shown he's not up to managing a biotech company responsibly. He may be squandering what was a solid cash reserve that should have permitted Celldex to reach commercialization without any additional funding.
Less than eleven months ago Celldex had about $300 million in the bank. Wise management of that cash reserve should have enabled the company to survive as an independent biotech through one or two commercial launches.
Marucci seems to have been too ambitious and aggressive. He seems to have counted on both Rindo and Glemba becoming commercialized by 2016. Well, Glemba is now out of that picture and unless ReACT data will support an early approval of Rindo in 2015 it looks like Rindo might not make that timeframe either because ACT IV has been delayed.
The fear is that Marucci might have squandered and continue to be squandering capital reserves.
Marucci has been spending money as if he's not worried about running out of it. I hope it's because he has known the ReACT data will be superb even though he cannot reveal it to investors yet. On November 14 we will know, and Marucci will either be vindicated or be someone whom the townsfolk might want to consider chasing out of the village.
By the way, bingo, it hit $14.05, but not in the way you were expecting. I never expected this. But I think it is testament to how nervous the market is about Marucci fumbling the ball yet again.
Management has burned the wrong people. I suspect that if CLDX does climb back up to $30 it will be a long, hard slog with extraordinary resistance unless ReACT results are a game-changer.
Management's decision to amend METRIC's trial protocol is not a good sign. The company is going to run out of cash before it can generate revenue unless Rindo is approved by 2016. Rindo is the company's only hope to start generating sales revenue by that year, but ACT IV's completion has been delayed at least six months.
The company's financial future is dicey even though it has $224 million cash. It's spending $30 million per quarter and will run out in two years if there is no revenue.
Investors are slamming the company because its financial future is shaky. If Rindo suffers a setback, the company will be desperate for a cash inflow in order to remain solvent.
Roth Capital analyst Joseph Pantginis reiterated a Buy rating on Celldex Therapeutics (NASDAQ:CLDX) with a $40 price target, following the company’s third-quarter results, posting EPS of ($0.31) and revenue of $1.1 million.
Pantginis noted, “With multiple data milestones on the horizon and the initiation of several highly-anticipated combination studies expected in 4Q, we believe CLDX remains a premier immunotherapy player to watch going into 2015.”
November 14th is going to be the most pivotal day this year, possibly even for the next twelve months, for Celldex's future. I will reassess my investment in this company after the CC on that date.
I still maintain that ReACT results are going to be tremendously positive. If I didn't believe that, I would be closing my position today. Management has been less than trustworthy over the past year. If ReACT turns out to be another disappointment, that's the last straw.
Marucci is spending nearly $30 million per quarter with no revenue stream in sight unless Rindo can be approved early in 2015.
Fug, I hope you're right about the buyout. After yesterday's earnings report with the METRIC modification, my confidence in management took a big hit. I'd welcome a buyout.
Even with $224 million or so, CLDX has huge money problems.
A Republican governor in ILLINOIS too! The incumbent candidate BHO campaigned for lost in BHO's home state.
From the 3Q PR: "We look forward to presenting data from the rindo program in recurrent GBM at the SNO meeting this month and completing planning for a number of new studies across our pipeline, including the initiation of the combination varlilumab and nivolumab study," concluded Marucci."
That sort of language in past PRs has been an indication that forthcoming data will be positive. Why would the company "look forward" to presenting poor data?
There have been so many tells that ReACT data will be positive. A blind person could connect the dots because they are so prominent as to almost be like Braille. The question is, "How positive are the data?"
I'm maintaining the ReACT data will be highly positive, for that is what makes most sense in my mind of Marucci's actions in hiring and preparing a marketing and sales force and in speaking so enthusiastically and with increasing confidence and optimism about Rindo commercialization for the past nine months. I'm hoping that the data will be good enough to support an application for early approval from the FDA.
Here's another statement from the PR that stands out: "Target enrollment (n=700) in ACT IV, the Phase 3 registration study of newly diagnosed patients with GBM has been reached. Given the lack of treatment options for patients with GBM, previously screened patients who are positive for the EGFRvIII mutation will be allowed to enter the study before enrollment is formally completed later this year."
Allowing unneeded screened patients who are EGFRviii+ to remain in the study is truly a compassionate and honorable decision, and I commend Marucci for that. It shows his concern for GBM patients who have almost no other treatment options, and if Rindo does work well then giving the patients Rindo is their best chance.
The fact that these GBM patients have almost no other options is a factor that I believe will weigh heavily in an FDA decision to grant early approval for Rindo based on outstanding ReACT results.
Sentiment: Strong Buy
Temporal, there's another factor you're neglecting: cash burn and cash reserves. Rindo is the only treatment that now has a chance of being approved by 2017. But Celldex runs out of cash at the end of 2016. Your point that *merely* adequate data would be sufficient from a scientific standpoint is true. However, Celldex is a business, so there is a business standpoint as well.
From the business standpoint, *merely* adequate data won't cut it because it won't be enough to assure Celldex of financial solvency by 2017. Stupendous data that would lead to early approval for Rindo would assure financial solvency for the company because it would generate a revenue stream that would offset the staggeringly high quarterly burn rate of nearly $30 million.
With *merely* adequate data, there will probably be no commercialization of Rindo until late 2016 because of the delay in ACT IV's patient accrual. Even assuming ACT IV meets its primary endpoint and Rindo is approved, sales wouldn't begin until 2017. But Celldex would have run out of cash in 2016.
What concerns investors like me is, looking two years down the road, what is the business plan for ensuring that the company can remain solvent through to commercialization? Will there be another secondary? At what share price? If it were offered today, it's likely the offering would be at $11 or so. Our investment would be further diluted. We don't want the financial or business side of the company to be a Sword of Damocles hanging over the company's neck.
Marucci has been hiring and prepping a marketing and sales force. He'd better have a damn good reason for doing so in 2014 if commercialization isn't expected until 2017.
Now I suspect Marucci has been prepping for early approval of Rindo in 2015 based on ReACT. I don't know, but that is what I think. That is what makes the most sense of Marucci's actions in my mind. That is why I expect ReACT to produce stellar data.
If it underwhelms, AM has business explaining to do.
Sentiment: Strong Buy
G&A Expenses: General and administrative (G&A) expenses were $5.0 million in the third quarter of 2014 and $14.4 million for the nine months ended September 30, 2014, compared to $3.6 million and $10.1 million for the comparable periods in 2013. The increase in G&A expenses was primarily attributable to higher personnel-related expenses and == rindopepimut and glembatumumab vedotin commercial planning costs in 2014.
"rindopepimut... commercial planning costs."
If Marucci doesn't expect and doesn't have evidence that Rindo will be commercialized in 2015, then he is wasting company money with commercial preparation in 2014.
Marucci has spoken quite a lot about how prepared Celldex is going to be for Rindo commercialization: "we're going to hit the ground running." I hope so. I sincerely hope so. But those preparations will have been wastefully premature if ReACT turns out to have underwhelming data.
I have said it many times since August, and some of the longs on this board are tired of hearing it, but it is the absolute truth. The ReACT data will be the most pivotal event for Celldex's future this year. Marucci knows the data. He has had some idea about the data's trend for at least the past nine months. He knows what cards he's holding, and he knows that he has not been at liberty to disclose what he knows to investors. Yet all this year Marucci has spoken in glowing terms about Rindo commercialization and assembled a sales force with many years of experience in oncology marketing. And all this year he has been spending company money like it won't run out.
Marucci's optimistic words and lavish expenditures only make sense if Rindo commercialization is a virtual certainty based on highly positive ReACT data. If the data are inadequate to support early approval, you have to ask what Marucci has been thinking and why he has acted and spoken the way he has for nine months.
November 14 is the day of reckoning. Marucci's credibility is seriously on the line.
Sentiment: Strong Buy