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Not true. There was already a Phase 2a. Yes, Alpha will run a phase 2, but it will be a, 2b and likely with the improved B foam or some other retention medium. With Alpha running the show, it could be under less stringent requirements than those demanded by the FDA.
Since we are guessing, my guess is the upfront was in the range of $10 million. It would appear Alpha doesn’t like disclosing upfront money for IPs. So, we wait for the next balance sheet in a financial.
IPIX would only have to disclose the payments received during the period covered by the filing. Since it appears the close of the deal and any payment took place after the fiscal year, there would be no requirement to disclose any amount received in the next 10k. For the next 10q, only money received would be require posting on the balance sheet. Not sure the exact amount of upfront payment would be outlined in the discussion section other than reproducing language already reported in the 8K. Again, my understanding is only the money’s actually received would need reporting and then on the balance sheet.
Icing is sweeter and more sugary than frosting. Icing is often used on pastries, while frosting is fluffier, richer and includes more fat. Frosting covers the cake while icing can refer to the decorative additional layering. As a metaphor for IPIX, frosting and icing would be a base deal followed by additional details and further development.
If the company took in a billion dollars last year, and valuation of the company is some multiple of that billion dollar revenue, then wouldn’t the partner be a multi-billion dollar company? That’s how it’s done for public companies, yes?
Some quick thoughts:
1) this is a first deal for an undeveloped drug (UP/UPS) with only a human proof of concept Phase 2 trial. The licensee is responsible for all development costs.
2) there is still all other gastrointestinal Brilacidin drugs as well as the most lucrative OM.
3) the next licenses will be far better due to the indications at that point being more advanced clinically.
4) IPIX is still working on improved B-OM plus time-release capsules for upper and lower GI. Once those are done, more licenses and advanced phase testing.
This is only the beginning, though I had hoped for a little better first terms.
Hey, Pete: were you referring to a super secret, secrecy clause? Or, the standard, boilerplate NDA language in a term sheet? Just curious.
If a term sheet is still effective, why would one expect a notice of any kind? Do you have evidence that a term sheet expired or canceled? Just asking. I know of no material proof, so I would be grateful for any evidence of such an event.
Term sheets nearly always include non-disclosure (secrecy) language. Pros know this.
There’s a very good reason for not going after pancreatic cancer. It’s a cancer that’s difficult to detect due to the pancreas’s ability to function normally until the cancer is late stage 3/4. The most effective treatment is resection, but there has to be something left to the pancreas to resection. Consequently, by the time PC is diagnosed there is nothing left that’s treatable. Kevetrin treatment would involve apoptosis of cancer cells in a vital organ that’s pretty much all cancer. A patient with a treatable cancer (stage 1/2) would be a candidate for a very effective resection.
Hey Wild, I don’t know anything new—good or bad. Some of the current delay (which some think is proof of agreement failure) has to do with reformulation and packaging. These things do take time due to Chemistry, Manufacturing, Controls (CMC) requirements. Brilacidin-IB is undergoing reformulation to a pill or capsule, B-OM is not only undergoing sachets packaging but also additional work to affect viscosity after mixing, and for B-UP IPIX is playing with best delivery (foam, enema mix, time delay pill, etc.). All this work, while nowhere near as expensive as a trial, still consumes time. Nonetheless, I think testing for at least one indication is approaching conclusion and is most likely written into at least one term sheet.
All the above are in the PRs of the last year.
P.S. All is well and safe abroad.
To what extent they were successful in subletting space, no doubt including the lab area as a turn-key facility, will be outlined in the 10K after June 30. Last 10K was filed Sept 11.
Thanks for posting this: “In the interim, we are planning to sublet laboratory space as we are now focused on conducting clinical studies.”
I can’t answer that, but it was originally the home of KARD, a preclinical development CRO.
They are paying $19k a month mostly for lab space. It’s a fully equipped lab. It ain’t empty.
“If it hit $79,...”
This board will be vacated long before...
What would make B-UC disruptive? To me it’s in your post: affordable...small molecule...tablet form. Add to that the low systemic exposure and you have something very desirable, but not yet on the market, with the potential of few or no side effects.
That’s nonsense. The price is yet to reflect any kind of deal and 3rd party validation.
Well all, have a great Memorial Day weekend. I’ll see you on the other side as we start what I hope is the big push to close out the fiscal year (year end June 30) with a big win.
I’m still here and adding as I free up funds.
What about Canadian, Saudi, Russian, or even Israeli based trading groups? Are there not off-shore market makers with or using US based market platforms? These are 2 good questions to ask yourself.
Brownian motion mechanics theory include identified patterns that emerge from random fluid movements based on such things as temperature changes and density. Brownian movement is a chaos pattern.
Brownian Motion: Order from Chaos
Anyone following that advice which first surfaced a few weeks back, plenty of time to buy, would have missed more than a triple. an almost 90% one day run means there is a great deal of momo which means (IMO) at least 60 cents by weekend, but more probably 80 before a correction just ahead of or immediately after news.
Second issue, “no reason for rise”:
1) anyone in this biopharma arena knows that IPIX is still greatly undervalued for a phase 3 enabled company. It should be minimally double today’s closing price.
2) O/S released Monday showed an O/S of less than 200mm shares. While that’s not the fully diluted count, it is at least 20mm less than most estimates. That alone is reason enough for a run above .25.
3) US trading rules are difficult to enforce against off-shore accounts, in particular those dealing with insider trading, and especially those dealing with leaks regarding EU regulatory outcomes.
4) keeping #3 in mind, it’s every bit possible that several things happened these last several days. IPIX received very favorable guidance and terms for an EU-based phase 3 trial that dovetails well with the FDA’s. The BP is finalizing its offer based on this feedback. There are now firm plans for a EU trial which is cheaper, less rigorous, and faster than a US trial.
One can wait if one wants, but by the time a correction sets in and news gives 100% assurance, one will be trying to accumulate above a buck fifty. That will surely make a nice double, though.
Of course there are patterns. Even chaos is a pattern. There are indeed patterns, and there are entire industries of theories based on interpretation of those patterns. It’s just a matter of which theory of patterns, and attendant explanations, one follows. The most followed, as well as for some most reviled, pattern analyst is Clay Trader. Belief in the meaning of patterns can even create self-fulfilling interpretations, yet another pattern influenced by a large following of traders.
Who was talking about ABSSSI? I wasn’t in that last post.
There is a big difference between early trials done by a startup and a pivotal trial powered by a BP. All the previous trials were at or less than my previous estimates. How much was the cost of the complete OM phase 2? Well if you consider that data from ABSSSI was included in the end of phase 2 meeting, but the OM trial itself was well within my estimates.
For BP, it’s not just the upfront money, it’s also the next pivotal trial costs and milestones. Trial costs may exceed $100 million and milestones are likely to include the start of trials and successful interim results. They would be on the hook for as much as 120 million to 200 million. That’s not a rounding error even for the biggest BP and its drug development budget.
Geez, LR, none of that was my point. Unless, you are arguing that sixteen-and-a-half months are close to 2 years. I don’t see that anywhere in your reply to my post. Do we really need gross exaggeration?
Your time line is inaccurate. Since January 2018 is not “close to 2 years.” It’s barely close to 17 months.
You guys shove it down. It just pops back up. Frustrating, yes?
If Brilacidin is no longer phase 2, and now approved for phase 3, please tell us how you would describe a phase 3 ready drug? It certainly isn’t phase 0, 1 or 2.
Brilacidin OM and Brilacidin ABSSI are two different drugs, the first administered orally the second administered by injection. Only the active ingredient is the same. Two applications, two unrelated diseases, two treatments, two deliveries, two separate sets of preclinical and clinical data and testing equals two drugs. If they were the same drug then the FDA would only ask for a bridge study and not a new INDA (investigational new drug application).
I agree.
Because the Term Sheet wasn’t reported in the 10q you and others concluded its dead? The 10q is unaudited and does not include every active document once documents are reported in a 10k. When the term sheet is not reported in the next 10k, then we can conclude it’s dead. The term sheet is still active until it’s reported as inactive in the annual report.
A pro would know this.
So, advanced discussions after 1 year is coming up ‘snake eyes’? Ah, I see, 1 year in dog years, maybe? Yeah, I can see how that might be a long time.
Can you define “advanced discussions” for us? I’m unclear of the meaning for the term in your usage. Would these discussions entail a final contract or might they be discussions for values based on what a party wants to see before discussions for finalizing? Would those discussions be before an end-of-phase or might they be before? In other words, what are you suggesting as previous “advanced discussions” that might cause one to conclude they came up “snake eyes” (i.e. failed)? Also, are you suggesting a partner would not be looking for patent and IP protection?
You said:
“Ipix has been down the advanced discussions road before and came up snake eyes. A new patent won’t change that.”
So, you don’t think final terms for a deal weren’t waiting for the patent issue for B-OM? You don’t think that extending the patent protection doesn’t add value to the IP for a partner? Interesting.
Total bullshit.
It’s one thing to speculate on the potential value of an asset; it’s something else entirely to do the same for market value for the company holding that asset. As I frequently said 10 years ago, let’s get to $1 first.
And, here we are again....
Thank you for the clarification. In my morning daze, I may have missed that.
I was reacting to the constant claims of selling without evidence. Primary case is Aruda, who filed recently not because required, but (IMO) because s/he/they wanted to show they are still holding over 6 million shares after 5 years of claims they are sellers.
Were they sellers? At one point, yes. Recent years under $? Unlikely.
“But why then would there be a need for a Beneficial Ownership Limitation that considers the MFO's holdings as a single beneficial owner?”
Because the MFO can function both as a collective single owner and individual owners. Ownership by proxy or individually are not mutually exclusive conditions in the case of a MFO (unlike say an Aspire type entity). Both conditions can exist simultaneously depending on situational advantages. Therefore, that clause exists to limit combined MFO ownership to less than 5%. I’m sure you can think of reasons that IPIX and Leo would not want a single group to hold such a large voting block of shares.
Correct me if I’m wrong, but I seem to recall that the preconversion shares have no voting power.
That in no way is proof that the MFO is selling or not selling. An MFO is not a single entity buying and selling. Rather it is a single office representing multiple accounts and assets of multiple families. So, the MFO could hold IPIX in a single joint ownership, or divide those assets into family allotments. Any one family can hold or sell independently of the others.
A collectively negotiated deal held individually would not necessarily trigger a 5% filing.