Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
except...
A large group of outside experts at the FDA has slapped down Alkermes’ campaign to gain an approval for their depression drug ALKS-5461, objecting to a messy set of data and the way the biotech managed the study and reported the data.
from here: https://endpts.com/fda-experts-gun-down-alkermes-pitch-for-alks-5461-slamming-the-company-on-multiple-fronts/?utm_medium=email&utm_campaign=600%20Nov%2011218%20JJ%20axes%20CD28%20autoimmune%20partnership%20Experts%20question%20Amarins%20early%20touting%20of%20Vascepa%20data&utm_content=600%20Nov%2011218%20JJ%20axes%20CD28%20autoimmune%20partnership%20Experts%20question%20Amarins%20early%20touting%20of%20Vascepa%20data+CID_37f57d46eba0400c2b26b05c61e74ea8&utm_source=ENDPOINTS%20emails&utm_term=FDA%20experts%20gun%20down%20Alkermes%20pitch%20for%20ALKS-5461%20slamming%20the%20company%20on%20multiple%20fronts
... unless the partner is global and needs EMA approval for EU region distribution/sales. Then process wouldn't be predicated upon just FDA.
Possible interest related to Kevetrin?
Pediatric safety profile?
FDA lists 205 molecular targets for pediatric cancer research
good point...
...we like clean BUTTS and we cannot lie....
...likely predicated upon the FDA meeting to close P2 and determine path forward...
...while Leo is quoted in the PR's, I'm pretty sure he's not actually 'authoring' them.
Some could be getting lost in translation, but there are some pretty critical components that would seem to be driving public sentiment, and certainly wouldn't be omitted in any sort of deal-structure.
This is irritatingly vague, as always (the PR).
Agreed, but a little confused about specifically what Leo was saying here:
many thanks Empiricst1 :)
No drink required yet... let's get IPIX across the line where we're in a position to uplist and can start either getting some of the refinement work completed to get products to market, or be acquired by someone who can!
I feel like something's happening currently, and while as shareholders we're still largely in the dark, piecing together some of the crumbs buried in SEC filings is helpful in its own way.
Cheers!
Rental Agreement for Office...
Not sure why nobody on here did this earlier, but in response to someone's earlier posted-question, the lease info from the property manager is Public Record Information.
I just phoned the landlord's office, found the name of the account manager for Ste 151-B, and enquired as to the current status. They couldn't divulge specific terms, but a new lease has been signed, and nobody's left the unit... so IPIX is still in the building.
I guess that's good news in some respects.
Further quoted-language-wise, this would appear to be M&A prep. Something's going on.
...maybe minus the SEC fine for misleading investors-part...
2nd...
These are my concerns, articulated once again echoing concerns with management... not to mention the gibberish-PR’s that contradict themselves periodically which further seem to erode public confidence in what’s going on. Minimal transparency and despite p2 trial-completions across multiple fronts.. zero partnerships etc.
NOT good news, and it’s not disputable.
(I’m a supporter and a non-insignificant investor holding a ‘Long’ position, but also a realist).
...which is my point, precisely...!
What the hell is taking so damn long?
Opportunity-cost for letting the clock run on product-development within this industry is potentially massive.
yes... the 'trouble on the financial side' is the confusing part of this puzzle.
Ther ARE dollars out there in all sorts of various forms... WHY is it SUCH a struggle to fund these efforts if the science is there and has been 'validated'.
This is my 'business management concern'.
...yes, quite familiar with 'deals' and what's required.
Certainly hopeful for the future with IPIX.
I'm a long as well, with a not insignificant investment tied up in the science, and I too and a believer in what's to come. But as a Business Developer, there are things that don't quite make sense with respect to what's happening based on the info they put out there to the public. I'm hoping there's a PR-disconnect between what we're 'hearing' and what's actually happening.
thanks for clarifying this, George... my memory wasn't serving me well, and I'd just finished making dinner when I saw a reply and had a few other thoughts rolling around in my head...
W/o diving deep into the DD and numbers behind science, if memory serves, our mechanism of delivery is easier (wasn't their product IV-based?), and I thought we posted better initial numbers, but please don't quote me.
My concern is: WTF has been going ON with IPIX for a year almost now, concerning this financial situation. Other companies are FUNDED. We're sitting around waiting for... what? We don't even have results for the P trial from LAST DECEMBER. Is this a joke? Even if you 'couldn't imagine unforeseen costs related to getting the results from the CRO', are you kidding me that you're pinching things SO close that you can't even keep the lights on and are now laying people off of your already tiny company, can't get the results of your trial that has blockbuster potential, and now have possibly even veered-away from what you declared as a 'signed-term-sheet' in a 10-K... and for what? Because you aren't running the business by grounding yourselves with 'sound business principles'?
I GET IPIX being a 'pre-revenue-bio' company. But the time is NOW to execute and to realize a revenue stream from one of the products that they've been developing within their 'value-based pipeline'. Shit or get off the pot... literally, that's what its come down to. Were they honestly thinking that they were really THAT close to a deal that they could walk away from Aspire, torch the milestones where first it was announced that they were on track to meet... and now they're announcing that none will be met?
The drums are beating in the background and getting louder. Galera has BTD designation for their OM compound. I appreciate that there's a dire need for a solution here, and the market can support many options, but let's GET something TO MARKET, LEO. This is beyond absurd. IPIX has SO much potential, but we're seeing VERY little action related to actually monetizing products and pushing things out the door. Nothing comes from making excuses. Actions are everything. Fluffy and nonsensical PR's are exactly that. Let's see some real action for a change. Eh?
OM BTD news across the segment:
So this is how it's done.. just fyi.. and this has always been my concern with the pace of development/progress with IPIX.
Not a 'doom-and-gloom' post here at all, but rather just a heads-up on what's happening with similar products, elsewhere in the industry.
Time matters: https://endpts.com/clarus-spearheads-a-big-150m-raise-so-galera-can-flip-the-phiii-card-on-its-new-drug-to-treat-radiation-effects/
Galera gets BTD, $150M for a PIII, and they expect to get the P3 underway in the next Q. Meanwhile we can't even get results for P that was completed last Dec... This is concerning.
...nope wasn’t lost on me at all actually.
What CELG walked away from was the option to license navicixizumab, a bispecific antibody that became OncoMed’s lead asset after mid stage failures caused issues with several other candidates...
Apparently CELG is holding onto options to license 2 others pipeline hopefuls- an anti-TIGIT monoclonal antibody and an anti—RSPO3 antibody.
What I got from this was: there’s potential room to acquire another product in the oncology-dept and given the nature of Kevetrin, it might not be the worst possible candidate for them to have interest-in, esp if they were having a long hard look at IPIX from the M&A side of things.
Why not remove competition or bolster your portfolio to corner the market with Psoriasis compounds, esp if the safety profile for Prur is more human-friendly? Why not include the Brilicidin franchise? Why not include Prurisol?
BOTH Kevetrin and navicixizumab are targeting indications related to Ovarian Cancer... why would CELG have signed over $177.25M to partner originally with OncoMed on its cancer programs only to throw in the towel?
Less than favorable results from a handful of other products for other indications? Doesn’t sound too plausible... total deal on the table was worth $3.3B.
What if that money is perhaps better spent wrapped up in a package to include other products with another small company that’s taken trials further across more indications with more a more diverse pipeline, and that company happens to be in-distress?
If I were in the M&A game, this is the scenario I’d be looking at. Beyond the balance-sheet considerations that seem obvious, there’s the IP value that matters likely more, and assessing complimentary value with a BP’s existing portfolio and the amount of trial info behind them and the work still required to bring a marketable product to approval... What’s the cost? What if Leo et.al are over all of this? What if the price is right? The packaging would seem to make sense...
Just kicking it around, since after the contradictory PR and 10-K there seems to be some pieces to assemble, since transparency doesn’t seem to be IPX’s strong suit...
...just last night?
This has been an ongoing curiosity for some time now with Otezla being possibly bettered by Prurisol... hence our need for those P2b results, stat.
Guessing the oncology team at CELG can likely take over for any sort of K research/re-formulation etc. I Think the point that it's functional was proven already. Now the applications and further trials are required, and cash is needed. Perhaps Menon is not, in the scheme of things, if CELG acquisition is potentially at-hand.
...the issue is more related to the underlying business fundamentals with a R/S.. not necessarily a 'good product'.
'Researchers at the Stern School of Business at NYU and Emory University looked at more than 40 years of data, from 1962 to 2001, and found that of the 1,600 reverse splits, shares underperformed their non-split peers by 15.6% in the first year following the split, 36% in the second year and 54% in the third year.'
'Of course, while the shares may get an initial boost, don’t expect it to last. If a company’s fortunes—and shares—have been waning, savvy investors will see the reverse split as a big red flag and continue selling, sending the share price back down.
Most—although not all—reverse stock splits are seen in small penny stocks that have not been able to attain steady profitability and create value for their shareholders. I found that was the case in most of the biotechs’ recent reverse splits. Many are on the verge of bankruptcy, and they use a reverse split as a last-ditch effort to revive their failing fortunes.'
- https://cabotwealth.com/daily/how-to-invest/reverse-stock-splits-shareholders/
I don't have the answers... I wish I did. The CDA engaged in by both IPIX and any interested parties would likely preclude their ability to discuss timeframes concerning when DD would have begun etc.
This is one of the issues I have regarding the rampant speculation around here, and given the ultra-confusing PR coming out of IPIX, I find it hard to understand how folks seem to be able to extrapolate much from the limited data provided on their end.
Much is negotiable if both parties agree when it comes to writing contracts, so we literally have no idea what's on the table (aside from what was stated in the recent announcement), timelines etc. I'm guessing that a BP would; having seen IPIX's 10-K etc, have an understanding of the timeliness of a deal and what that would likely mean for IPIX's existential concerns.
The other notion that 'the company isn't worth anything if the SP is in the toilet' is a little confusing.
The BP would be interested in their patent-developments and trial-progress.
They're not purchasing IPIX's ability to run an accounting firm or business consultancy... They're after drugs for their own inventory to either augment existing products, remove a competitive situation (CELG/Otezla), or expanding the scope of their current portfolios.
Based on where things stand currently, small-trial-sizes excepted, we have progress that's likely of interest on some level to some global players (https://clinicaltrials.gov/ct2/results?term=cellceutix&Search=Search)
Patents are worth $. Management may or may not be asked to stick around in the event of a buyout/M&A situation... we have no idea. The drugs are the value. SP doesn't reflect current value.
I'm not so sure the concern here is whether or not things work, as much as the timeline related to making business decisions and keeping the lights-on.
Being a public company, there are a lot of unanswered questions and stability related issues that need to be addressed before we're insolvent.
Based on the recent balance sheet (10-k) filed, there's a very real concern related to how they're going to keep moving things forward.
The amount of time for DD to be done by a BP if they're 'interested' would be longer than IPIX can survive at their current burn-rate w/o sourcing financing.
‘Planning’ vs ‘execution.
Have you ever planned to take a check to deposit to your bank, vs actually depositing a check in the bank?
You either have the money or you don’t.
This is a binary event.
BTD has either been filed-for, or it hasn’t. We have zero concrete evidence to support the filing.
So why is the PR author playing games?
People on here are trying to calculate terms related to file-dates when we don’t even have a date.
We know the window for approval is 60 days from filing with the FDA. Yet..... what... ?
Apologies, I should've clarified... with respect to the milestone-stuff, their PR's that mention it etc.
Sure BTD is important, but hyping it when there's not even a meeting on the books seems meaningless?
There's zero mention of any concrete date, whether an actual submission was made or not etc.
I don't understand the misleading statements. You either file for it or you don't.
I hate... no... DESPISE games when people play them, companies play them etc.
Just be transparent and cut the BS.
FILE for BTD and then let us know.
Or DON'T file for it, and surprise the shareholders if you get it, and if you don't, nobody is the wiser.
It's happened before, and it'll happen again.
But these incessant PR releases that mean little in light of the dire situation IPIX finds itself in currently, seem to only erode shareholder confidence further within the community that's already ages-short of it. (the SP seems to reflect this, along with subsequent downward trends from most PR's over the last year+)
The thing i can't seem to get my head around is: why is everyone assuming that BTD has been filed-for?
Nowhere has it been said that it's been filed?
The mention of 'planning a meeting with the FDA' literally means nothing.
I 'plan to have meetings' all the time. I also 'plan to do the laundry', 'plan to clean my bike', 'plan to remember to get more coffee beans from the store' etc, yet somehow randomly they don't always seem to actually happen?
Yeah, all good questions for sure.
The company's lack of transparency here isn't making things easier.
I feel like there's a lot of forensic accounting analysis going on around here (on the board) to try to dissect the 10-K, when I guess if we wait for another week or so, we'll hopefully just have the answers we're seeking.
If it's $4m they needed, I agree that it should've been just written into the agreement, unless they're a LOT further along contract-wise with a prospective BP, or unless they have some sort of other product that doesn't require FDA approval (Derm topical or something) that's a spinoff of B, that's ready to roll out EOM. Sell other stuff for other indications that haven't been hyped, generate revenue, ditch Aspire, keep marching... ?
I dunno. Just spitballing here..
My understanding was the total amount to get Prur out-of-hoc and to receive complete results was $8M.
That was as of end of winter (Feb) or so.
My guess is that outstanding $4M represents the 50% of the unpaid amount the CRO is still owed.
I sort of feel like (and have learned) that there should be a contingency plan for EVERYthing!
Yeah... worth consideration for sure.
I can’t imagine them having over $1M worth of travel in such a short amount of time, unless the prospective BP is abroad?
I didn’t pick the sheet apart for that level of detail yet, but not that we should have to I wouldn’t think.
I’m not quite understanding the seeming total lack of transparency here, aside from possible CDA concerns... but if all but one have evaporated, a little enlightenment would sure go a long way given the SP over the last year?
Institutional investors traditionally are restricted (except Hedge funds) from investing in OTC based organizations...
As I mentioned: I believe in the science.. My questions relate to the business structure and management and deal-making concerns. Running a business has literally nothing to do with the science of the products. Making a balance sheet work, negotiating a deal, and being willing to restructure debt etc, are different skills entirely.
I'm a Biologist (educational background), but with business school on top of it... along with a handful of other successful business ventures behind me. Science is science. Business is business. You can be great at science and not so great at business... and that's OK. But surrounding yourself with folks who KNOW how to walk through a deal, rescue a business in trouble etc, are necessary things on occasion (independent of the goings-on in the lab). This is one of those occasions where some critical decisions need to be made, and I'm hoping there aren't egos in the room clouding judgment for the sake of all involved (shareholders, recipients of possible drugs in pipeline etc).
Not sure it's 'over'. I think a little (lot) of financial creativity and business management skills are critical at this juncture. This is when thinking outside the proverbial box will likely be the make/break deal for IPIX.
The irony is I'm sitting on a Real Estate development project that's been facing similar conditions. We have a land-owner who's a little ego-centric and pride and a severely depressed personal economic situation are driving a chain of bad-decisions.
Possibly throwing a loss-leader out there in the form of a single indication license to CELG for Prur with an instant cash payout and no-royalties could help to get things solvent around here, and then have them pay the $2M odd dollars for the completion of the data-compilation and delivery? Maybe some sort of revenue-share deal/partnership favourable to CELG even, just to get the ball rolling, if B is the blockbuster franchise that we seem to believe it is?
I don't know what they're looking at or entertaining at this point, since their timeline seems to have entailed some CDA-entertainment (with quite low-completion odds working against them), and little else to show for anything outside the completed (small) trials.
I'd like to think that with the brain power in the room over there, that they're exhausting all creative options, but my concern I think, is that they're not prepared to burn either a license for a single indication to generate revenue to allow them to proceed (belief in un-leveraged-sums may be clouding judgment) or feel they're painted into a toxic-financing corner somehow due to operating in an 'echo-chamber' of sorts (confirmation of belief).
I'm a 'long' and still holding. I'm literally hundreds of thousands-down currently (70%+) and have dragged others into this based on the science and the belief that it was actually going somewhere.
Total among friends, we have over $1M invested in this, and it's frustrating to see things where they are.
I've been asking questions, but nobody at HQ responds to anything, ever.
I believe in the science, but I'm questioning the management of the deal-making.
Their communications are some of the most confusing and nonsensical/contradictory of any corporate communications I've seen (I have a background in marketing and business management).
The 10-K was a reality-check, and I'm not sure what their strategy looks like from here.
Based on volume over the last 2 days, we've seen some 2M shares change hands... seems like mostly downward pressure in volume. Depending on how their 'future/pending deal' is structured, it could possibly prove helpful to stakeholders (if anything actually happens).
Toxic financing doesn't help, and I'm not quite understanding why the Aspire/Aruda deal was the only option available to them. A solid partnership would be most helpful. A sale of a product or license for an indication would be great. I don't know how much BTD matters at this point, as their burn-rate would likely see them into bankruptcy before they could get partnership paperwork together and finalized to capitalize on the designation award?
Fumbling Prurisol and losing the timing-advantage... is leaving the door open for bigger/better funded entities to get competing products to market: Article to BMS Ps-candidate
How on earth did the funding to get the Prurisol data get miscalculated? Seems pretty damn basic... I'd even asked someone close to this if they needed cash back in Feb, and he replied 'we have the cash'.
WTF?
...these are the dots i connected as well, after seeing this PR.
No such thing as 'coincidence', and the host just so happens to be Celgene...?
I do love the moronic and condescending retorts on here that are given without thought, but do dearly wish some would recognize the value of products IPIX has taken through P2 trials, acknowledge the existing market, competition, and intrinsic value that a partner to assist with progression to a fully-realized product for market, brings to the table in the M&A/buyout situation. Market Cap is not commensurate with the value of pipeline products, and a buyout based solely on SP isn't what's likely being discussed currently behind closed-doors.
'Please consult your financial advisor. They will explain it. It’s really elementary. '
here's one: https://www.fiercebiotech.com/biotech/affimed-lands-big-backloaded-immunotherapy-deal-genentech-sending-its-stock-into-overdrive?mkt_tok=eyJpIjoiTkRFeU1EUmxaV1ZpWTJWaCIsInQiOiJpN0lydDVrdFNoR0VjQUNkVDg5R3M1OGRoNFc0eWhcL1FOaGhFTWY3TWdQNTdsdWpuWXdReDhiUWtRYlBORFB5ZVZ3K1hzS25EUW0zUEF4aitCMnkrcTNSQUM2Z2V1ZlhzakFLWnhDNlZXUWh2aEJNb3Z1VE5meWI4VyswWVFwNUMifQ%3D%3D&mrkid=74197490
Milestones and upfront payments for further development seem to be closer to the standard. There have been a handful of outright buyouts over the last 8mo or so, but I guess it depends on the pipeline and progress.
Not sure why people are saying that 'a buyout depends on the cap', when the cap reflects nothing related to value of the products within this sector attributable to the respective companies in question. If Bril-OM has a street value over the course of 10yrs of X, based on competitor sales/projected sales, then how on earth does that reflect on a market-cap price for a company if the SP doesn't reflect the value of the actual product. If an M&A is being considered, assets are calculated etc, and values are assessed. Patents ARE value with this stuff. They're not reflected in the SP though, mostly because this is a PRE-revenue company. People seem to be forgetting this.
I don't understand the 'logic' behind so many arguments on here, and I guess the waiting game and lack of updates is making some folks a little nutty. I get it.
I'm confused. What are you basing a $.75 'buyout' upon?
Based on my math, at current cap and PPS that would cap this out at $118.27M
Why would you think mgmnt would even remotely consider entertaining something like that, knowing the approximate market value of what they've been working to develop?
Seems like a pretty severe (understatement) undercut of value to me?