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Kevetrin has not failed. We will be developing an oral form for use in future trials once funds become available.
Will you write one once you have 7 figure gains in IPIX?
What makes you think the original term sheet has apparently be dropped? I don't believe we have received any news to make a determination one way or the other.
Since then we have added additional patents, did gastric B tests, conducted EOP2 with the FDA, established EU and Irish subsidiaries. Is the term sheet gone or are we just checking off items on it before inking it?
Doesnt seem to be a way to tell.
The risk for pharma is putting more cash upfront. In a buyout, all cash is upfront and at risk.
$50M upfront + $700M in sales milestones is less risk than a $200M buyout. There is no risk in paying royalties because by that point, success is assured.
BP will provide guidance and direction in a partnership if you are worried about the competence of leadership.
A partnership is less risk than a buyout since they put up significantly less upfront money and pay out more to IPIX once success is assured (royalties and milestones).
You don't seem to have a good grasp of how partnerships vs buyouts work.
Why would IPIX financials scare potential partners? The financing is why IPIX is even entertaining the potential partners in the first place. Partners have cash/marketing and want drug candidates. IPIX has drug candidates and needs cash/marketing.
IPIX financials make potential partners very interested because it means they are likely to get a good deal on a set of drug candidates. They wouldn't normally get as good a deal when negotiating with a financially healthy partner.
I have been in numerous tech/biotech companies that turned ended up being failures or outright frauds on both the NASDAQ and OTC. I have never seen one get hammered on a message board as badly as IPIX year after year after year.
Things have really fallen apart for IPIX in the past year. We can refute claims and provide deal comps til we're blue in the face but at this point it really does little good. All we can do is hope a deal comes through and that Leo is right about the market substantially undervaluing the pipeline.
We've been dealt a number of bad hands here. I'm all-in on IPIX with the few chips I have left on the table.
None of these are indicative of Kevetrin not working. You don't know Kevetrin doesn't work, you simply believe Kevetrin doesn't work. It's an important distinction.
Partners or buyers don't want our company, they want the drug candidates. While it does partially influence what they will pay, the current financial situation doesn't determine whether they want our drugs.
BP has leadership, they don't want ours.
BP has cash, they don't want ours.
BP needs drug candidates, they want ours.
Leo isn't running a scam. He definitely has his weaknesses but his integrity is not one of them:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=146295564
Right. That was our understanding up until recently. If that's the case, why would we only be partnering B-OM/B-IBD.
If we can do it by indication, why are we not partnering on the less valuable, more advanced, almost certain to succeed antibiotic indication?
It looks like frrol answered them all except for the ABSSSI part. It was our largest, most advanced, and decisively successful trial. B-ABSSSI has an extremely high chance of success in phase 3 and for NDA. I haven't heard anyone argue against that.
The question remains...why haven't we partnered it?
1. The trial costs were too high for us to take it on solo.
2. The value may be lower than what the company thought. Some speculated that it might be held in reserve behind cheaper generic antibiotics for much of the patent life.
3. We used to think that doing a deal on ABSSSI would complicate deal making or give away too much value before the larger anti-inflammatory conditions were explored. I'm not sure this still holds as we appear to be doing a deal on just anti-inflammatory at this time. Could we not do an ABSSSI deal now?
We don't have a good answer. It irks me because ABSSSI is what brought me here. It looked like a shoe-in for success. If it doesn't get started in the next year or two what will it be worth with little time left on the patent?
You keep missing the point. Kevetrin is worth money with no clinical trials (as demonstrated by those massive pre-clinical deals I cited). With a successful phase 1 you add more value. The two patients in the phase 2 are just a little cherry on top, not the meat of the value.
Forget about the phase 2. Value Kevetrin based on being a preclinical p53 modulator that has proven to be relatively safe in a phase 1.
Another example of $80 million upfront on a pair of targets still in phase 1 from just last month:
https://endpts.com/celgene-bets-80m-on-immunometabolism-in-first-partnership-deal-since-bristol-myers-announced-74b-buyout/?utm_medium=email&utm_campaign=646%20Fri%20011818&utm_content=646%20Fri%20011818+CID_2c8a2b081305fa484ef792cfd978a9f0&utm_source=ENDPOINTS%20emails&utm_term=Celgene%20inks%20first%20deals%20since%20Bristol-Myers%20announced%2074B%20buyout%20%20bets%2080M%20on%20immunometabolism
Kevetrin has plenty of partnership value with 2/2 in a phase 2a.
Here's a big old list of massive preclinical and phase 1 deals that I provided you just a few weeks ago:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145781762
It may be, it may not be.
I think what is currently holding up a deal is that IPIX is going shopping. Advanced discussions with multiple pharma companies are being conducted to find the best price. Once the team is satisfied that they have a fair deal, they will sign on the dotted line.
I suspect what is on offer at this time is considerably less than what Leo and many here would like, but it will still drive our market cap considerably higher than it is now.
This is going to be a very profitable investment for people who get a good chunk of shares here. Those $3-4.93 shares are going to be underwater for a long time to come. Those dreaming of $3/share will be handsomely rewarded. Those dreaming of $30+/share will either be very disappointed or in this stock for a very long time to come.
Obviously all talk from the company as of late has been regarding partnership. My ears prick up when I hear you mention buyout.
I know you're not a big speculator on deal valuations. Would you indulge us on what you feel could be pulled on a buyout at this time? I won't ask you to tell me yours without telling you mine.
I'm thinking the following:
With the loss of Prurisol and apparent disinterest in ABSSSI, we'd probably be looking at a buyout in the $300 million to $500 million range with upside to $700 million if the buyer is particularly interested in Kevetrin.
Thanks.
Anything is possible with a small N.
We do have the historical rate of SOM in placebo arms of other larger trials available us. Given that data, we have a strong reason to believe that the placebo rate of SOM was significantly lower than normal in the B-OM trial.
We didn't have that luxury/support when reaching for the bright spot in the Prurisol 2a trial. It's safe to say we won't see such a low placebo SOM incidence in a trial with 200 people. The secondary numbers relating to duration of severe OM also help provide support for some B-OM efficacy over placebo.
Agreed on your points. It is unfortunate that the Cisplatin qw arm showed such a low placebo rate. It appears as though either there was a mix up of results in that arm or we were simply the victim of small numbers of patients. In this case, an extra placebo patient or two avoiding SOM can completely throw off the results. Unfortunately, as you note, we can't assume that the Cisplatin qw B-OM group didn't benefit from the same luck (weather, baromatric pressure, cheery nursing staff, flavor of jello, etc.) that caused the placebo group to have such low rates of SOM.
I do hope, if we get a deal and a fresh start, that IPIX will execute slightly larger phase 2a trials in the future. Just an extra five patients in each arm could have helped to provide a significantly clearer signal. We appear to have been bitten by this in the Prurisol 2a trials and now are suffering for not investing a bit more into the B-OM trial. Hopefully this just results in a more expensive and thorough phase 3 rather than an outright failure like Prurisol.
I'm not entirely convinced that we will end up going straight to phase 3 on this. I could see a partner wanting to do a fast phase 2b to ensure that it is a slam dunk before committing funds to it...depending on the sizing requested by the FDA. We're waiting patiently for details on that from IPIX it seems.
I highly doubt the FDA will have any concerns regarding the B-ABSSSI adverse effects when considering B-OM and B-UP.
B-ABSSSI phase 2a saw blood pressure issues when Polymedix carried out the trial because the dosage was too high. These adverse effects were mitigated with a lower dosage in the phase 2b carried out by Cellceutix. Note that this is an intravenous indication (the drug is delivered directly into the blood stream for those who don't know).
B-OM and B-UP trials both had secondary outcome measures of Brilacidin concentrations in plasma. This tells us how much Brilacidin when delivered in water, as a swish/spit or enema, is absorbed through the mucosa into the blood stream.
B-OM PK data revealed "no measurable Brilacidin Concentrations in plasma" during weekly collection from six patients.
B-UP demonstrated "no apparent clinically significant trends observed for blood chemistry, hematology, urinalysis" in it's phase 2a.
https://static1.squarespace.com/static/5715352e20c647639137f992/t/596cac7df14aa1a6e7118ed8/1500294274057/IPI+DDTWC+Brilacidin+presentation+%28final-u%29+13Jul2017.pdf
Absorbtion is negligible. Let's use a little napkin math to determine how negligible:
B-OM specifically showed < 10 ng/mL of Brilacidin in blood plasma.
0.6mg/kg was the effective lower B-ABSSSI dose.
Average human male has 70ml of blood per kilogram of body weight.
1 mg = 1,000,000 ng
1kg = ~70ml blood
B-ABSSSI = 0.6mg/70ml blood = 600,000ng/70ml = 8571ng/ml
B-OM = < 10ng/ml
So the worst case assumed measurement of B-OM results in the lowest dose of B-ABSSSI having 857 times higher blood concentration. If we use the higher B-ABSSSI dose from the phase 2B and allow some flexibility of "less than" 10ng/ml, the difference between the two exceeds 1000x.
Based on these numbers, the FDA will have no concern regarding any problems that existed in the B-ABSSSI trials.
Ok. So we're talking 5-6+ NDA approvals with successful marketing, no competitors, and 10 years. Sure, I guess IPIX could become a mid-large cap pharmaceutical company like REGN. That's a long way from here.
I'm investing on the plan to get a deal which grants solvency, third-party validation, and a path back to a fair valuation of $200-600 million for now. Hoping for additional partnerships on Kevetrin and B indications along with additional trial starts and milestone payments to get us up to the billion dollar valuation and hit new highs.
$300/share? How do you get there?
I'm hoping for solvency and $3/share while dreaming of $13/share. I doubt we ever see $30/share let alone $300/share.
I look forward to rapid expansion of development if we are able to swing a sizeable upfront.
Acne, HS, and atopic dermatitis (eczema) will likely be topical or subcutaneous treatments and should have a high rate of preclinical efficacy translating to clinical efficacy. Additionally, risk of adverse effects should be low. These would be areas where Dr. Bertolino shines with his dermatology background.
Nothing to do but wait and find out if we're getting $10 million upfront or $100+ million upfront or somewhere in between.
We're not at that point. There is enough in the pipeline that we could raise capital to get to a deal. It might cost 10, 20, 40, or 100 million shares to raise $2 million but it could be done in a survival situation.
There's always another couple million laying around. It's all a question of where it will come from and how many shares will it cost?
Drug partnership?
Equity stake by larger pharma?
Loan from the CEO?
The three wise men?
2M share sale to Aspire?
8M share sale to Aspire?
12M share sale to the MFO?
XXM share sale to next financier?
Lots of possibilities especially if you ratchet up the number of shares on offer. Plenty of hope, just a matter of how.
I consider it dead and buried in 2018. Its time to look for B and K on the horizon.
A little dilution to get us to a much bigger deal isn't really dilution. Hopefully we just get a nice deal soon. My cat is four too but doesn't play cards. Clarity and transparency regarding the Prurisol 2B trial was crappy at all stages...its obvious why now...the stock price would have tanked earlier than it did. I too like Boca and winning. Many fun memories. Otherwise CEO tries to be candid and transparent. I like the cut of his jib. Good things to come.
That is probably what is going on right now. A go-shop period if you will.
My guess is the following: A big negotiation has taken place, possibly with the same term sheet partner from the summer, and that BP is confident they have given a fair offer. We are likely on an abbreviated tour of bidders to ensure we aren't missing a substantially better offer elsewhere. If nothing big turns up we will likely sign with our suitor. If there is something much more promising we might get some bridge financing to continue negotiations.
We're going to need a pretty sizeable deal to move this $2+ in a single day.
$2/share = $360 million in market cap with no further dilution.
Here's to hoping Leo can pull one of those Theravance/Protagonist sized deals for Brilacidin.
Ah that really was a while back. Obviously it was not selected for publication. Not knowing which journal he submitted to there is no telling what percentage of submissions were published.
Not being published based off a single submission to a highly selective journal would have little bearing on the quality of both the submission or the underlying drug.
I couldn't find a PR stating that an article was ever submitted. Was this a hearsay email that is lost to the winds of time? Any evidence that this actually occurred?
Another good Kevetrin comparison from a couple months ago. This was a cash starved company too.
https://seekingalpha.com/article/4230252-agenus-gets-hail-mary-cash-infusion-gilead-sciences
Agenus received $120 million upfront + $30 million equity investment with $1.7 billion in fees and milestones for three preclinical I/O targets with an option for two more.
Ignore the fact that Kevetrin did a phase 1 and a tiny phase 2. Divide those numbers by 3 if you want to place Kevetrin on equal footing to the I/O targets. That's $40 million upfront with $565 million in milestones.
Plenty of value in Kevetrin as-is.
I see you're making this a daily copy/paste so let's hash it out.
Phone autocorrected 8K to 4k. Good catch, thanks!
Here is another Kevetrin deal comparison:
https://www.fiercebiotech.com/biotech/harpoon-files-86m-ipo-to-help-fund-its-t-cell-engager-platform
Harpoon Therapeutics
$340M market cap. (they recently raised about $70 million cash)
HPN424 Prostate cancer - Conducting phase 1 (Started in 2018)
3 other preclinical indications at this time