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Well...it can get considerably worse. Anyone who has read the latest 10-Q knows that everything is on the line. That, of course, is true of any stock. It becomes especially relevant when it is specifically spelled out in a 10-Q though.
The latest 10-Q is available here:
http://myedgarpdf.com/datafeed2/?url=https://www.sec.gov/Archives/edgar/data/1355250/000147793219000383/0001477932-19-000383-index.htm
From page 24:
Be cool honey bunny. Be cool.
Deal is coming but its going to get worse before it gets better. Either buy some more cheap shares or turn off the computer for a few weeks.
Nothing to do but buy, wait, and pray.
The hope is that they will strike a pipeline deal with a pharma company.
Most of the debt is owed to officers of the company in the form of loans and back pay.
People should be worried but the upside is very large if they manage a drug deal. High risk, high reward.
It's not about what you want, it is about drawing a conclusion with an incomplete set of facts. We simply don't have enough data to conclude whether the term sheet is terminated or in place. Therefore, the term sheet is still in play. That doesn't mean it is still in place (it could be terminated already), only that it has not been removed from the realm of possibilities.
First paragraph made me chuckle. Thank you.
A fair assesment on your part as well. Making an assertion either way about the term sheet requires confirmation bias. There is too little concrete information to work from. One just has to place their bets.
Yeah, but why bother? In this case we know there is a European pharma partner interested in Brilacidin. Why would we have done the B-UP trial in Europe? Likely because it will have more weight with the EMA.
No proof, just connecting dots as an alternative to the "term sheet is dead" narrative floating around:
B-UP (IBD) trial held in Europe.
Term sheet global pharma partner interested in OM/IBD.
Additional Brilacidin patents added since term sheet.
Brilacidin resilience against gastric fluid tested.
EU subsidiary established.
Sure sounds like the global pharma partner wants to do a phase 3 OM trial along with some phase 2 IBD trials to me. Sounds like some others do too now that the 11th hour has approached. Let's find out who wants it most.
My guess is the MFO provided us with a bit more cash and they are shorting to improve their conversion price.
They have the shelf for direct sales into the market for financing. If they can't swing a deal in time, they simply have to weigh ATM dilution against ceasing operations and selling the company.
If the shelf sales are used to reach a good partnership deal later this year the stock will suffer short term but it will be the best option.
The company will survive just fine, it's all a question of at what cost? The sooner they get a deal done the better.
Odds have never been better in the history of the company to see a deal PR than in the next three weeks. Expect volatility followed by a big up or down as we close in on the end of the month.
Well then I stand by the statement: Either deal(good), dilution (bad), or cease operations (worst). It really is that simple as that contains every possibility. The important part is the company said that this would need to happen in the quarter ending 3/31 in the last 10-Q. The wait will soon be over for some results.
RS is just rearranging the share structure if needed to optimize one of the above solutions. It doesn't help/hurt/solve our problem on its own.
What is an example of an unexpected event that doesn't fit into one of these categories?
Pipeline Deal - good (this has been our goal for nearly a decade)
1. Any partnership, licensing deal, equity stake, or buyout with another pharma or development company interested in developing the pipeline.
Self-Financing - not great
1. Financing deal with a firm like Aspire or MFO.
2. ATM sales using the shelf.
3. Another personal loan from the CEO or investors.
Cease Operations - worst
1. Find a buyer of last resort
2. Fold the company
It seems to be a ternary to me: Succeed, fail, or muddle through. If your guess is that it will be something that doesn't fit into these categories, can you give an example of what you're thinking? Help me think outside the box.
What awaits Kevetrin in the near term? What would a deal look like if we cut one now? Let's look at some comps.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145781762
$80M upfront on 2 preclinical targets
$640M upfront + $1.5B milestones on 1 phase 1 PD-1 copycat
$150M upfront + $2.4B milestones on 10 preclinical targets
$225M upfront + $2.4B milestones on two phase 1 targets
$80M upfront + $2.8B milestones on a grab bag of preclinical targets
$200M upfront + $2.8B milestones on four preclinical targets
Kevetrin could likely do a deal worth far more than our current market cap of $25M. The comps above should ease the worries of even those who are terribly distraught about only have 2 patients (both successful) in the phase 2 trial.
It's actually warming up. 40's and 50's over the next few weeks. Share price headed there shortly when Leo gives us a glimpse of the good to come.
Could have a pharma deal announced on Monday. No way to tell and it's all speculation. But yes, I'm thinking the most likely scenario is additional bridge financing and soon. IPIX has shown that it is consistently overoptimistic at predicting when and if certain events will happen. It needs the padding badly.
Deal is coming. These things always take longer than expected. You have been here over four years. What's another month or two?
Maybe, but the company has said it will likely need a new source of funding by 3/31 to continue operations. We're likely to see one of three announcements in the next four weeks:
A pharma deal - good. (up a dollar)
A bad bridge financing deal - not good. (down a nickel?)
Ceasing operations, exploring sale - bad. (down a dime)
The recent PRs suggest we're setting up a deal in Europe. Unfortunately, the closer we get to 3/31, the more likely one of the two bad options is.
We'll have news by the end of the month. Either up a dollar or down a dime.
Not to worry JT. We'll make plenty of money on partnership deals long before FDA approvals come into play. We're still a couple years from worrying about NDA approvals unless we get a BTD.
It wasn't all a pump/dump before. We had stellar trial results in a phase 2b for a novel antibiotic. It is almost certain to succeed in phase 3 and back in 2014/2015 Cubicin was purchased for billions (Leo made sure to note this).
We were a much stronger company at the start of 2015:
-Phase 2B ABSSSI just completed
-Imminent phase 3 and B Partnership
-NASDAQ uplisting just around the corner
-Sponsored Kevetrin Phase 2 on the horizon
-A report of spleen lesion disappearance in Kevetrin Phase 1
-All the potential in the world for Prurisol with stellar preclinicals.
-Solid and rising stock price with a good Aspire deal for funding following multiple bouts of good news and milestones met.
Even though our current potential is higher with OM/IBD, IPIX Mar 2019 is significantly weaker than Cellceutix of Jan 2015:
-ABSSSI is on the shelf for now, probably pending other antimicrobal indications (acne, atopic dermatitis, HS)
-Prurisol wiped from the canvas after much blood/treasure was spent
-Kevetrin development stalled due to low funds, sponsored trial fell through, phase 2a ended after two patients (best case reason being we ran out of money)
-Attempting to strike a deal on significantly less robust trial results than before
-NASDAQ or even $1 no where in sight. Unattainable without a partnership deal.
-Nearly twice the outstanding share count as 2015 Cellceutix.
-No ability to raise meaningful funds without severe dilution outside of a deal, stock price in a 4-year downtrend. Funding deals became exponentially worse each time throughout 2018. All this on the heels of multiple missed milestones/deadlines culminating in a failed trial.
It's almost like looking at two entirely different companies even though the two pipelines are almost identical. It's all come down to a hope and a prayer that we can do a deal to shore up the balance sheet and save us.
2015 Cellceutix was a rapidly rising biotech with all the stars aligned. It was rightly valued at $4+ ($400-500 million) after a string of successes and fulfilled promises.
2019 Innovation Pharma is a do-or-die Hail Mary penny stock play. While our current $25 million market cap is probably a bit too low, we have no business being valued anywhere near $400 million without a partnership deal.
The balance sheet, momentum, and confidence are everything as we saw in 2014/2015. Once you lose control of one of those (or all three in our case) punishment is swift and severe on the OTC.
We're entering the final weeks of this iteration of the company. Will we go to the auction block or strike the deal and be reborn in the spirit of CTIX once again?
My money is on rising from the ashes. Bring it home Leo! Get that deal! Save those lives! God bless and be green all!
McEhrlich is about to break out the deal shillelagh. Green for miles.
It doesnt mean much but it sure feels good. Seeing a $0.20 print this week would be a dream come true.
Nonsense. It will likely be a global deal OR we're partnering for EU only and will be able to keep a larger slice of the pie in the US once victory is assured.
Wouldn't it be great to do that phase 3 in Europe and then land a massive 50-50 partnership for B-OM in the US with almost certain success rather than some piddly 9% royalty?
I'm not prepared to speculate on the non-serious adverse events in the trial and any role they played in the decision.
These are people with advanced and lethal cancers. This is a very different arena than Psoriasis or IBD where one weighs the side-effects against the symptoms of the disease. In this arena, the symptom of the disease is death, sooner rather than later, espeically in the cases of ovarian and pancreatic cancers.
People tolerate many of the listed events to gain extra months and years of life using traditional chemo and radiation therapies. If Kevetrin ends up helping send these cancers into remission most will gladly endure the side effects.
It was inconclusive and incomplete but Kevetrin was successful in the dosed patients for the evaluated endpoints.
Nothing measured in the trial produced an ounce of data to support your original statement that Kevetrin has failed.
How you want to classify the Kevetrin phase 2 trial is up to you but don't say the drug has failed.
Tumor response was a secondary endpoint. The company obviously didnt feel proceeding with the phase 2a trial format was a worthy use of very limited funds. I don't claim the trial was a success, I only object to it being used as justification that Kevetrin is a failed drug.
As for the funding, the situation wasn't as rosy as you recall. You can't just look at remaining Aspire money and Kevetrin costs in a vacuum. There were larger than expected outlays in early 2018 for the Prurisol trial. This was evident in the horrendous financing deals we arranged a few months later. A million or two more spent on the Kevetrin trial and we would have been out of cash by Christmas.
Management had to start pumping the brakes on spending and at that time the Kevetrin trial was the least likely to help is out of our near-term financial peril.
Develop Kevetrin, get Prurisol results, stay solvent. Choose two.
Obviously that won't happen as I doubt there are any successful trials with two participants.
I didnt say the trial was successful. IPIX failed to have enough funds to continue the Kevetrin phase 2 trial.
Kevetrin successfully met the endpoints of the trial in 100% (2/2) of dosed patients. Just a small taste of efficacy in humans which, combined with strong preclinical data, will justify developing an oral pill for additional phase 2 studies.
We have yet to see anything that indicates that Kevetrin does not work as we intend it to. Inability to continue a perfect trial due to lack of funds does not speak to a drugs success or failure.
I wouldn't say the trial was completed as intented but the drug didn't fail. The trial ended because we didn't have the funding to continue it. The two patients who were dosed met primary endpoints successfully.
If the two patients did not meet the biomarker endpoints and they pulled the plug to save cash I would be agreeing with you.
Couldn't say. It wasn't based on the evaluation of the first two patients since they saw success.
Dr. Menon is a very smart man.
Only Prurisol has failed.
All other IPIX drugs have successfully met endpoints in all their trials. The Kevetrin phase 2 was ended after 2/2 patients successfully met endpoints to conserve money. The plan is to develop all other drugs/indications in the pipeline once funding is available.
I did not say or intend to convey that the FDA did any comparison between GC4419 and B-OM. I was addressing both your comment and the one you were replying to.
GC4419 got BTD because it safely and substantially did better than placebo in all arms with significant numbers of patients (n=30).
GC4419 Cisplatin q3wk and qwk arms beat placebo and other competing drugs (Clonidine Lauriad, Palifermin, and SGX942) by a substantial margin.
GC4419 Cisplatin q3wk had n=30
B-OM q3wk arm beat all the drugs including GC4419 but only had n=8. Note the B-OM q3wk ITT n=8 was 25% (2/8) and the PP n=7 was 14.3% (1/7).
B-OM qwk was roughly equal to placebo.
A few extra getting SOM in the B-OM trial swings those numbers 10-30 percentage points higher. Add a few more incidences of SOM to any GC4419 arm and it still trounces placebo.
Granted, the B-OM placebo arm was significantly more effective than in any other trial. I'm not sure if that is good or bad. Did the weather or Jello that day serve to bolster both the placebo results and the B-OM results? No telling.
GC4419 had a large enough phase 2b trial and demonstrated substantial superiority against all other treatments aside from the small B-OM q3wk arm. It is almost certain to succeed in phase 3 and become the dominant OM treatment. This is why it received BTD.
Brilacidin-OM exhibited greater potential in the q3wk compared to GC4419. That, combined with being a mouth rinse vs IV, will make it the dominant treatment IF it replicates these numbers in phase 3. Given our small n, it is still much more of an IF compared to Galera's near certain phase 3 success. I believe that is why BTD was not granted to B-OM. If we replicate our q3wk arm with n=30 on an interim look I think we'll get BTD.
Galera investors are surely rooting for B-OM phase 3 failure as it is the only thing that can snatch billions/year away from them at this point.
There were leaks. In a post by wcsb he stated that the lowest estimated valuation for B-OM was $150M/year. No one seemed to lend any credence to it.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145777305
We're getting paid and soon!
Please review this DD I have provided you many times to allay your fears regarding 2/2 in a Phase 2 trial. This will be the fourth time I have pointed you to it. You never respond and seem to forget about it after a few days each time:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=145781762
$80M upfront on 2 preclinical targets
$640M upfront + $1.5B milestones on 1 phase 1 PD-1 copycat
$150M upfront + $2.4B milestones on 10 preclinical targets
$225M upfront + $2.4B milestones on two phase 1 targets
$80M upfront + $2.8B milestones on a grab bag of preclinical targets
$200M upfront + $2.8B milestones on four preclinical targets
Kevetrin could likely do a deal worth far more than our current market cap of $25M. The comps above should ease the worries of even those who are terribly distraught about only have 2 patients (both successful) in the phase 2 trial.
I suspect Leo could pick up the phone and sell Kevetrin for $50 million to a dozen pharma companies. The reason a deal on Kevetrin hasn't been done yet is the terms would be significantly less favorable than after a successful oral phase 2 trial.
We are left to speculate as only IPIX management knows what is on the table at this time.
BPs continue to pay hundreds of millions upfront for these immuno cancer drugs. Most of them that are not copy cats of PD-1 will fail.
Hopefully the next trial of Kevetrin will give us an idea of actual efficacy the modulation of p53 has on cancer cells in actual human patients. I think there is a reasonable chance we will see efficacy in a combo therapy. The disappearing tumor PR from the phase 1 has me hoping it will have some efficacy as a monotherapy as well.
Time will tell but the ever present point is that Kevetrin has a lot of value as-is. I look forward to striking a deal on it as the numbers could be staggering.
Nothing on that list has failed except for P. All others have met endooints in trials and development is continuing once funding is available.
Yeah...that's why every major BP with a market cap over $40 billion has an HQ or subsidiary in Ireland...because they have no chance of FDA approval.
Corporate tax shelter Dud. We're likely expecting large amounts of cash and milestones over the coming years from a European partner and don't want to pay US taxes on it.