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No it says: (1) US$ 1 million, upon Commencement of the First Phase III Clinical Trial; and
(2) US$ 1 million, upon the first filing of the Marketing Approval application to the US Regulatory Authority (“FDA”) or the EU Regulatory Authority (“EMA”), as applicable, without any duplication.
"initial payment in the amount set forth on Exhibit I..."
Of course there is no Exhibit I so we don't know what the initial payment is. However, it's safe to assume that is significantly less than $1million otherwise they would have told us the amount.
Thank you BooDog. You made my point. I was talking specifically about the "Weekly" regimen subgroup.
From IP's own press release:
Incidence of severe OM in Modified Intent to Treat (mITT) Population: Brilacidin 42.9%, Placebo 60.0%.
Now if you subtract the numbers from the "21 day" regimen, you will see that for the "weekly" regimen subgroup, the Placebo outperformed B-OM.
Also if you remember interim results were released which were fantastic, yet final results were only 42.9 to 60. Ok but not great. Again, shows results between interim and final were about even with placebo.
These are the facts based on IPIX's own press releases. Feel free to calculate for yourself.
Nice to see a voice of reason Infinity. The study was very small, a quarter of the patients got cut out of results (publishing MITT results is a red flag) and IPIX says the results were great for the "every 21 days" regimen, but if you do the math, that means for the "weekly" regimen, placebo out performed B-OM. Doesn't make a lot of sense unless you realize we are dealing with a very small sample size.
What RS stock is that?
You're correct. Aspire and Aruda each have millions of shares to liquidate. It was thought Aspire made a great deal at 25 center a share. Now it looks like they are going to lose big.
Actually it tells me this is not Aspire's first rodeo. They are making a fortune off of Leo and the shareholders.
TIAB,if they had a deal mostly wrapped up which is paying them over $10m upfront why in the world would they sell 16 million shares for only 25 cents each?
It's strange that just because added these potential milestones to the Aspire payment schedule, people are so confident they will come true. In my OPINION, the BTD and collaboration milestones have little or no chance of happening. The only possibility is the Prurisol results, but look out things such as "Modified Intent to treat" and "Per Protocol" where a significant percentage of patients are cut out from the results.
You do realize that Aspire has over 10 million shares to sell in the open market right? It's going to be tough to hold these levels for very long with that type of selling pressure.
Leo's PR purposely tried to mislead investors by saying they sold Aspire 5,263,158 shares at a market price of 38 cents, when in fact they sold Aspire 8,000,000 shares at steeply discounted 25 cents. Nothing illegal as the additional 2,736,842 shares are mentioned in the last paragraph as "commitment shares", but certainly formatted to mislead investors. So the sales tally for Aspire for this quarter is up to 16 million shares for a $4m raise. Assuming they've already sold 4 or 5 million shares into the market, we still have over 10 million shares left. Couple questions: Why did they PR this 8m share raise, but hid the previous one in the last 10q? What happened to the original $30m financing deal that was signed last year? Nobody knows.
Only on this board would a sale of 8 million shares for 25 cents per share be interpreted as good news. So now the tally is up to 16 million shares for $4m. Don't forget the the additional 8 millions free "call options" with a strike price of 38 cents. This is a fleecing pure and simple
Aspire likely does not have any insider information and will continue to slowly dump the remainder of their 8 million shares in the open market. 8 million is a ton of shares so they have to do it in a strategic manner or they risk tanking the stock to below their 25 cent purchase price.
Given how low the stock price is and how many shares it now takes IPIX to raise even $1m, Aspire likely demanded a much steeper financing discount given their risk has greatly increased.
This ATM arrangement can't last much longer and, unless IPIX can find another source of financing, their business appears doomed.
More than that, Infinity, 165 days since trials of any kind. No trials scheduled, no P results, oral-K on hold, pill/foam - B on hold, ABSSSI on hold, M taking 50% cut in salary, staff cuts, selling stock to Aspire for $.25 per share. Good times in Beverly MA.
Their development program for IBD are dependent upon available resources and include new formulations (oral and foam type) with potential associated toxicology studies and clinical studies to be defined.
If 25 cents is the threshold wouldn't they just do a reverse split to ensure the price doesn't fall below?
Looking at their definitions of outcome measures on clinicaltrial I see what you mean. Thank you.
Plenty, I got the Galera info from their press release:
In the intent-to-treat population, the 90 milligram (mg) dose of GC4419 met its primary endpoint, demonstrating a highly significant (p=0.024), clinically meaningful and dose-dependent reduction in the duration of SOM as defined by the World Health Organization as Grade 3 or 4
Looks like IP has cut their spending quite a bit and is not using Aspire as much. Could bode well near term for the stock price as a lot of selling pressure is being removed.
If a patient ultimately didn't receive the minimum cumulative radiation dose yet still developed SOM should that result be thrown out? BTW Galera reported ITT results in their 223 patient SOM trial.
12/11/17- initial data release somehow the initial n gets winnowed down from 61 then 55(mITT) and then further to 49(PP). data released relates to incidence of SOM
Sure they are mentioned in the inclusion criteria so they are eligible to participate in the trial. But it is not included anywhere in either the primary or secondary outcome measurements.
Sorry but this is classic data cherry picking. BTW there was nothing in the trial design mentioning high concentration vs. low concentration cisplatin.
Infinity
Once the full dataset has been unblinded, received and reviewed, the Company will release the results.
Hi Plenty, Great point and I completely agree. In fact the trial design has a secondary outcome measurement of "Total Number of Days with SOM.." It would have been nice to learn about that data.
ffrol, the press release said nothing about duration. In fact, duration didn't improve vs. placebo. If you look at the trial design, duration is defined as time from initial WHO Grade 3 to the final Grade 3 assessment before SOM never returns.
While Brilacidin-OM appeared to decrease the initial duration of SOM (time from the initial WHO Grade ≥ 3 to the first WHO Grade ≤ 2 OM assessment), detailed interpretation of this and other duration data comparisons were limited.
Once the full dataset has been unblinded, received and reviewed, the Company will release the results....
My guess is upcoming P results will show just enough to satisfy investors. However, the Psoriasis market is extremely crowded, well beyond Otezla. It took forever just to find enough patients to participate in phase 2b. Unless P shows blowout results, this indication is going nowhere and I highly doubt we'll ever see a phase 3.
Where is the 8K for B-OM trial results?
Guess they are not in quiet period after all.
Galera Therapeutics Receives FDA Breakthrough Therapy Designation for GC4419 for the Reduction of Severe Oral Mucositis
Designation Based on Positive Results of Phase 2b Trial of GC4419
Severe Oral Mucositis Affects 70 Percent of Head & Neck Cancer Patients Receiving Radiotherapy
February 28, 2018
---------------
Galera's phase 2b results were announced a week after Brilacidin yet GC4419 received BTD. If IPIX was going to receive BTD they would have already by now. Perhaps the FDA looked at the entire "intent-to-treat" data of the Brilacidin trial and was less than impressed. Us investors don't know because the data for 25% of the trial participants was never publicly released.
"Of the 61 patients randomized, 46 patients met the cumulative radiation dose criteria of at least 55 Gy..."
There are 15 patients who didn't receive at least 55Gy radiation. So IPIX cut them out of the results. However, did any of these patients develop severe OM? What bucket were they in? Why did they not receive 55 Gy radiation?
Stock is down nearly 50% since the release of OM top line data. Obviously investors are concerned.
I agree with you Dane. They've almost never gone this long without a PR. Some big news is brewing. Maybe it's a partnership. Maybe it's something bad. We'll know soon.
I would be surprised if Polymedix didn't have multiple CDAs with Pharmas considering PMX-30063(Brilacidin.) Any one of them could picked up the drug with pocket change once Poly went into bankruptcy. Nobody wanted this drug. And what exactly has IPIX done to move the Brilacidin forward besides tinker with the dosage?
Kevetrin has shown some encouraging signs modulating P53, but very little in the way of efficacy. Now they are going back to phase 1 once they complete their oral formulation. They started clinical trials in 2012!
Prurisol phase 2 didn't go well although the 200mg dosage showed some hope. We will find out soon how phase 2B goes, but given the lack of PRs, no interim results, and the sinking share price, it feels like there might be some bad news ahead on this front. But we don't know yet.
So where exactly will the partnership come from?
Farrell, one big difference when comparing both trials' reduction of incidence:
GC4419 reported a 34% reduction of SOM in their "Intent-to-treat" population. That means they are not cutting out any patients from their results. Everyone who participated in the trial is counted.
Brilacidin reported a 39% reduction in their "per protocol" population and 28% reduction on their "modified-intent-to-treat" population. No word at all from IPIX what the numbers are for the "intent-to-treat" population, but you can probably assume it is a lot lower than 28% or they would have reported them.
That's right frrol. The B-OM trial reported good but not great results in incidence of SOM, especially given what their interim results showed. However, those results were only reported for the "modified-intent-to-treat" and "per-protocol" groups. IPIX also released a chart showing delayed onset of SOM which looked great. However that was only for the "per-protocol" group (only 39 out of 61 patients!). The trial showed no improvement in Duration of SOM vs. placebo. Big negative. The company claims it didn't have enough data. Look at the duration numbers for Galera.
What are the stats for the "intent-to-treat" poplulation? 25% of an already small trial was not reported by IPIX. Of the 16 patients that did not receive at least 55Gy radiation, how many got severe OM? Why did they drop out of the trial before receiving at least 55Gy? Inquiring minds want to know.
MX, slight revision to your take. The IV formulation of Kevetrin is a bust. They never found a dosage that was effective because of such a short half life. They will theoretically start over with oral Kevetrin, but the last 10K said they weren't allocating much resource towards oral K so I wouldn't hold my breath waiting for an oral formulation. Will be far in the future, if ever.
I wouldn't hold my breath waiting for an oral formulation. Here is what the latest 10K says about IPIXs progress:
"...Compared to injectable or intravenous treatments, oral therapy is the preferred drug delivery method of patients. Preliminary laboratory studies are encouraging and support the potential of developing an oral formulation, but there are no assurances made or implied that the Company will be successful in completing development of an oral formulation. Toxicology studies for the oral formulation of Kevetrin began January 2017.
Resources allocated to these activities are, however, currently strategically measured in order to assure that adequate support is available for completion of critical clinical trial activities in the Brilacidin and Prurisol programs."
Sure JT I agree with you. I was just pointing out that you can't characterize the financials as wonderful when you are forced to sell tons of stock at depressed prices in order to fund your business. Now things can change in an instant with a partnership. They can kick Aspire to the curb and their financials really will be wonderful. Just need that partnership first!
Their financials are wonderful? Things will certainly change if they can put a partnership together but as of right now they have no cash (current ratio is well under 1) and have to use their 68 cent stock as an ATM in order fund their business. That's certainly not a wonderful position to be in.
Thanks for all the analysis TradingPro. The data looks pretty good. My only concern with the KM graph is it's only looking at the 39 "per protocol" patients. There were another 22 patients in the trial. I think it's fair to drop the 15 patients who didn't receive at least 55Gy radiation. However, why did those drop out and for what reason? Did they develop SOM even though they didn't receive 55Gy? It would be great to have those answers, but overall the data looks good and I'm sure it's enough to get a deal done in 2018.
Agree. It's nice to see someone crunching the data and not just "talking their book".