I'm surprised that no one has said they might be in negotiations for selling the company based on mRCC readout.
This news release is a good way to start the morning.
Immunotherapy is in it's infancy. I think that combo therapies will be how they grain traction. I think you can count the number approved therapies on one hand. Dendrion was one of them and look what happened. It worked but it was too expensive to compete with cheaper more conventional therapies.
Otherwise, it's failure after failure until there has been enough literature around a specific method/target to understand the problems well enough to get a drug approved.
I personally have my doubts about how effective some immuntherapies can be. Once you're body is in full resistance mode with viral antigens for example, it'll become more difficult to get the virus to the cell. That's why melanoma is a logical target because you can inject the virus directly into the cells. I suspect they might have to find a way to flush the antibodies from the cells prior to treatment. (If I were a shorting man, I would short the companies with the newest treatments that don't have failures in the area yet.)
In combinations, it might gain use earlier than alone.
Exelixis did report original data on Nov. 4, 2014. Do you really think that the SEC would be OK with what you're suggesting? Exelixis would still be liable. Exelixis has to approve it.
With all due respect: If you look, you'll find:
"In November 2011, Exelixis, the developer of the drug, entered into a Cooperative Research and Development Agreement with the National Cancer Institute’s Cancer Therapy Evaluation Program, making it available for investigation by cooperative groups. E1512 is a randomized, three‐arm phase II trial investigating the clinical efficacy and safety of erlotinib alone, cabozantinib alone, or erlotinib plus cabozantinib as second‐ or third‐line therapy in patients with EGFR wild‐type NSCLC. "
I in no way believe they'll be releasing new OS data there without an official press release as per SEC rules.
Releasing the data only at the meeting and not to the public would give a focused group to invest or divest in the stock with privileged information. shortnstocke is wrong.
Ah, Good news then. Let us know what the results are if this is indeed the case.
Why then does it say "This study is ongoing, but not recruiting participants." on the clinicaltrials site if it's complete?
That would be an extension of the "combo therapy" statement. Though they don't have data to show if the trial has not ended unless there was an interim analysis.
I would not expect any revelations beyond official press releases from the company. You might get more details about about clinical results from completed trials which might lead a paper they plan to publish. There is potential there but I don't expect much.
I'm on board with potential partnerships but trial results are too far off.
The reduced costs would have been factored into Deborah's comment.
The short term concern is money. With partnerships, they could get money up front but that is usually burned through the first 12 to 16 months which is not enough time to see a phase 1,2, and 3 to finish or a phase 3 alone.
It is clear that METEOR and CELESTIAL are the only big triggers on the horizon and the two scenarios exist where they either continue operations to regrow or they sell.
With success of mRCC, would the cash come quick enough to fund operations indefinitely and pay debt?
I'd like your thoughts on this: I've been mulling over this going concern issue and the lack of 12 months of cash or cash equivalents. The statement by Deborah seems a bit loaded and I'm wondering if there is anything to read into it. She is CFO and is going to pick words carefully.
1a. two major trials are wrapping up.
1b. investors want more than 12 months cash.
2. they have less than around 9 months cash at best.
3. they must have a plan, investors want it otherwise they're considered at risk for liquidation.
4. what is there plan?
I know of no plan; thus I have to assume liquidation of assets. It's been discussed here for quite some time but we're coming down to the wire with no plan offered by management.
A. they plan on succeeding in the trials.
A1. they sale their products (post job offer as such).
B they plan on failing the trials.
B1. they're in perpetual negotiation for liquidation of assets such as patents, ongoing asymmetric partnerships, etc.
B2. cut more weight and lean heavily on income from Cobi.
B3. sell Cobi et al.
The best case scenario, the longs win and Exelixis become the next Gilead. The worst case, we're looking at the value of Cobi. My low value on that buyout is $3.51 after debt without other assets. That's more than my average price. A pari-mutuel sell off would be better.
I guess there could be a bankruptcy and that would be worse; but I don't see why it would go there.
Excellent point but who is controlling European, Japan, Asia, South America distribution right now? It may already be in place for MTC.
And she never would. The bankruptcy would be announced without warning.
If you're reading wiki for guidance, let me put it this way:
The standard is more than 12 months cash and then it's considered a risk which presents the possible need to liquidate or curtail materially the scale of its operations. I didn't make it up, it's just the way it is. You can argue until you're blue in the face but the big boys are looking at this. People scream manipulation when the price does not go where they want it to but they're not analyzing the stock based on reality.
Exel do have income potentially starting at the end of the year but how much and it's not approved yet. Wouldn't Debbie Burke have included that as investments?
The one thing I did like it the idea of combo therapy with Cabo. This would require further partnerships which would yield quick cash infusions. If Cabo is successful on any level, this scenario has weight.
To be concise, they have less than 12 months cash.
The article quoted Debbie Burke as saying "As a further update to our cash position the company anticipates that cash, cash equivalents and short and long-term investments will be sufficient to fund our operations through the first quarter of 2016".