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I'll be pretty surprised if Leo discloses locations, manufacturing etc. My understanding of the location-secrecy is related to previous shareholder/s approaching past trial-sites and harassing them for whatever reasons.
I feel like he's pretty committed to not giving out any more info than he's legally required to provide (and also not prior-to when he's mandated to disclose either). Not that it helps anyone other than him, but that seems to be his M.O
JFM said: Expect big follow-up pop (maybe as early as Tomorrow Morning?)...when Leo complete's Farrell's list:
"Imagine how it will run when we receive the trial news:
If it's a 'double-blind' study which I believe it is... I'm not sure we're going to get any 'interim' results?
This is in mine IMHO... there are a lot of 'deep pockets' individual dipping their toes in the water for a 'Watch and see approach' making 50k to 100K buys.
When the PR's and results kick-in over the next couple of weeks and those confirmations on direction by the people on the sidelines are validated. We will be bumping on the $1 to $3 asks. Hoping that is the case. But, the news update by the AP news service has opened a lot of closed eyes for a second look.
By my estimate, for a 29day tracker per FDA, after first dosing, we should be hearing about Mid-Point results by 2/16 or 2/23.
Thank you for all the DD updates! Not you Runn and DUNN
I’m already tits-deep in shares and not buying more. It’ll be interesting to see what happens here for sure, and all I can do is hope for the best. The last 5yr hold-down has been brutal and I’m looking forward to the exit.
I wish the best for those working to make a difference here of course.
And thank for your constantly helpful info and updates as always!
I just snuck an edit into the post that affects the total issuance guesstimate but the gist of it remains the same. A large number of shares will be hitting the market in the near future IF the preferred investors are exercising their warrants (I believe that they are) and if the second tranche closes.
Re: "coordinating a series of 'group-buys' to drive SP" Do you know the name Jerry Williams...also known as "Monk"? He conducted similar efforts, using the term "locking down the float", to try to force a short squeeze. He bought shares of the companies he told his followers to buy, of course...even gave what he called seminars. Sometimes the shares responded, but the companies were weak so the results were inconsistent. He wasn't technically doing anything wrong until he started quietly unloading the shares of the companies that he was simultaneously "teaching" others to buy. The SEC filed a Complaint in District Court. It was an easy case to make.
It's not my business but manipulation in either direction tends to end bdly.
Fat Albert: Please read. These are the conversions I was referring to. What I said is NOT BS... SEC filings are not BS. I wanted you to have this info so you can time your buys if you're coordinating a series of 'group-buys' to drive SP. Awareness of the opposing selling-pressure and potential volume and limits might prove helpful (I know I'd want to be aware of them if I were considering a move as-such).
And LR, thank you for the update. I knew you'd have the figures that I didn't.
I'm quoting you here for FA and others, just in case:
VERY broad strokes: The first tranche of the deal included 3M preferred shares and 2 batches of 3M warrants each convertible to preferred. That's about $9M worth available to convert to common at 85% of some recent share price (forgive my laziness). The closing share price since 12/9 has ranged from $.17 to $.25. Taking 85% of $.20 (for ease of math) gives a conversion price of $.17. So if ALL the warrants are exercised and ALL the preferred is converted to common (and that $.17 applies to all of it) the $9M would buy the investors about 53M shares. Obviously, some of those preferred shares have been converted and some of the common shares have been sold so we have no idea where things stand in terms of shares outstanding and won't until a few weeks from now (10Q). Even then we won't know how much common the preferred investors are holding. They WOULD have an obligation to file a Schedule 13G if they got to a 5% holding (as with Aspire, they won't). Nowadays that would amount to 18-19M shares.
Lots of "ifs".
FWIW the Prospectus Supplement says this: Shares of Class A common stock to be outstanding after this offering "Up to 470.1 million shares assuming sale of 15,267 shares of Series B-2 preferred stock and conversion of such shares of Series B-2 preferred stock into 114.1 million shares of our Class A common stock at a conversion price of $0.1445 per share, which is 85% the closing price of our common stock on the OTCQB on December 1, 2020."
I copied and pasted the SEC filing excerpts related to the material agreement IPIX entered into that supersedes the Aspire agreement, with the new MFO.
The MFO that's been selling into the market still likely has a ton of shares. Not hundreds of thousands.. not millions... possibly a hundred million (possibly slightly less, I haven't been tracking since the amended SP agreement).
(a) On the First Closing Date, upon the terms and subject to the conditions set forth herein, the Company agrees to sell, and the Purchasers, severally and not jointly, agree to purchase, an aggregate of 3,053 shares of Preferred Stock, 3,053 Series 1 Warrants and 3,053 Series 2 Warrants for a total purchase price of $3,000,000 (each share being purchased for $982.50). Each Purchaser shall deliver to the Company, via wire transfer or a certified check, immediately available funds equal to its Subscription Amount as set forth on the signature page hereto executed by such Purchaser, and the Company shall deliver to each Purchaser its respective First Closing Shares and Warrants, as determined pursuant to Section 2.2(a), and the Company and each Purchaser shall deliver the other items set forth in Section 2.2 deliverable at the Closing. Upon satisfaction of the covenants and conditions set forth in Sections 2.2 and 2.3, the Closing shall occur at the offices of NMRS or such other location as the parties shall mutually agree. The Company covenants that, if the Purchaser delivers a Notice of Conversion (as defined in the Certificate of Designation) to convert any Closing Shares between the date hereof and 12:00 p.m. (New York City time) on the First Closing Date, the Company shall deliver Conversion Shares subject to such Notice(s) of Conversion to the Purchaser by 4:00 p.m. (New York City time) on the First Closing Date.
THEN, on or around 9 March 2021 you're going to see this likely happen:
(b) On the Second Closing Date, upon the terms and subject to the conditions set forth herein, the Company agrees to sell, and the Purchasers, severally and not jointly, agree to purchase, an aggregate of 2,036 shares of Preferred Stock, 2,036 Series 1 Warrants and 2,036 Series 2 Warrants for a total purchase price of $2,000,000 (each share being purchased for $982.50). Each Purchaser shall deliver to the Company, via wire transfer or a certified check, immediately available funds equal to its Subscription Amount as set forth on the signature page hereto executed by such Purchaser, and the Company shall deliver to each Purchaser its respective Second Closing Shares and Warrants, as determined pursuant to Section 2.2(d), and the Company and each Purchaser shall deliver the other items set forth in Section 2.2 deliverable at the Closing. Upon satisfaction of the covenants and conditions set forth in Sections 2.2 and 2.3, the Closing shall occur at the offices of NMRS or such other location as the parties shall mutually agree. The Company covenants that, if the Purchaser delivers a Notice of Conversion (as defined in the Certificate of Designation) to convert any Closing Shares between the date hereof and 12:00 p.m. (New York City time) on the Second Closing Date, the Company shall deliver Conversion Shares subject to such Notice(s) of Conversion to the Purchaser by 4:00 p.m. (New York City time) on the Second Closing Date.
This is relevant on the daily:
(c) The respective obligations of the Purchasers hereunder in connection with the Second Closing are subject to the following conditions (the “Equity Conditions”) being met:
1. Minimum trading price of the stock for each of the past 10 trading days prior to the 2nd Closing date shall be greater than $0.07 and
2. Minimum daily dollar volume of the stock for each of the past 10 trading days prior to the 2nd Closing date shall be greater than $50,000.
Something to consider balancing, if you're going in heavy. Depending on volume on the day and SP.
The reason I'm saying this is:
4.3 Acknowledgment of Dilution. The Company acknowledges that the issuance of the Securities may result in dilution of the outstanding shares of Common Stock, which dilution may be substantial under certain market conditions. The Company further acknowledges that its obligations under the Transaction Documents, including, without limitation, its obligation to issue the Conversion Shares and Warrant Shares pursuant to the Transaction Documents, are unconditional and absolute and not subject to any right of set off, counterclaim, delay or reduction, regardless of the effect of any such dilution or any claim the Company may have against any Purchaser and regardless of the dilutive effect that such issuance may have on the ownership of the other stockholders of the Company.
I don't know what the MFO's outstanding currently is... not even generally. Guessing OG or LR may have an idea though, so might be worth looking for them to weigh-in before you burn a stack of cash on something that may not have much traction. Timing on this could be fairly important.
Collectively there is a lot of money and anything they have I can double myself.
First thing big money usually does is research who's involved. Second here would be company infrastructure and history of progression.
I can't recall ever having seen a story on IPIX in FirstWord, a mainstay of the pharma info world. Ever, hope I am wrong. Has anyone else? Wonder if Leo or others from IPIX have tried to supply updates, been turned down, or whatever? As I grab off a few more two dime shares, as I will soon do, the thought of this still bothers me. And it should.
Oh.... sorry... was IPIX about to run a trial on something? I’ve seen nothing but PR’s for 11mo, but nothing trial-related in the detail department so far?
I was under the impression that IPIX had transitioned into being just a PR agency and away from aspirations of being a ‘pharmaceutical company’? (PR, dilute, pay-Leo... that’s the cycle)
Where’s Leo?
Where are the trial locations? Who’s the CRO domestically? Abroad? (they’ve been pumping the news of ‘international trials’)
There’s been MORE than enough time to get a trial running, evidenced by the thousands of others trials underway and listed on CT.gov
So again... ‘what trial’?
COVID? projected start: 4Q 2020. It’s almost Feb ‘21. IBD?
C’mon.
IPIX's trial... The focus on this board "the past 2 days" is/was GME stock which was shorted heavily and has rebounded due to a coordinated effort from website's and chat-boards to buy shares. Some here thought posting about IPIX would draw interest.. If anything, it will cause more to short since the float is low... 2 million...
The first three patients enrolled tolerated treatment well and improved rapidly. Each of the three patients was discharged from the hospital within a week of starting the patient’s COVI-MSC infusions and two patients were discharged on the day of their last infusion. One of the patients had been in the hospital for three weeks, unable to be weaned from significant oxygen support, and another patient with uncontrolled diabetes had been discharged previously but had to be readmitted due to recurrent ARD. Each of the infusions were well-tolerated and no patient reported any infusion-related adverse events. A fourth patient is currently at the beginning of a course of treatment, with no safety issues following the patient’s first infusion. Additional enrollment continues.
How quickly could a Brilacidin infusion see people recovering enough to be discharged? Will we ever find out?
All these other companies with COVID related plays can get clear and concise info out there. Why not IPIX?
HT- I appreciate your history with the company, and mine is similar. I've done what I can to connect Leo with funding, network etc, and he's taken literally none of what I've brought to his table. Very peculiar.
I've been in for not as long as you (5yrs), to the tune of hundreds of thousands of $'s. (closer to $1M now :/ )
I HAVE believed Leo based on the PR's and the filings, and so I've bought more based on each apparent 'pump', only to have him selling into the news and watching the SP decline. As you know, this has been the pattern for years on top of years. There's never been any follow-through. Would you not agree? Yet you still maintain faith in 'management'? How?
For me to walk away from -80%, when I believe the science is 'sound', would be crazy to me. My concern is management. I'm hoping that the contractors are of more help now, and I'm holding out for an M&A related to C19, which is why I would like to hear something about the trial. (and also why he suddenly needed a supplemental funding mechanism to supersede Aspire)
I'm keenly aware however of the fact that 'good science dies at the hands of bad management', which I'm hoping is not the case here.
Hope we find a resolution somewhere soon that suits the public as well as the shareholders, and I hope you are able to see a handsome return on your investment in return for your decade of patience.
Thank you for your question.
Now I have been invested for over 10+ years in CTIX/IPIX. Now I’ve seen my portfolio go severely down from my first purchases to the tune of a couple hundred thousand dollars in the negative, but decided to stick it out because I believed in the science behind Kevetrin and Brilacidin. And because of the downturn in share price I have even been able to better my cost average greatly during this downturn in SP the past years and increase my share count that I hold. I’ve voiced my concerns to the company that going after Prurisol was a mistake in my opinion even if it was the quickest way to generating cash flow and for even not raising enough capital when the share price was over $3.00 a share back then years ago.
So my question to you is this -
Why did you or even now do you not sell your shares and move on if you truly do not have faith either in Leo, the company or the drugs? Just an honest question. TIA
Thanks for your insightful posts. They’re appreciated... if not by the ‘naked-short-conspiracy-crowd’, then by the folks here who understand and appreciate business and financial mechanisms and the economics of the business environment.
I feel like we need an M&A situation and the trial. This timeline is grotesque for shareholders with long-positions. Leo’s waaaay over his head and needs competence in leadership to see this through.
Here’s my post that covered the preferred financing deal that was done in 2018 (post about 2018 financing). That deal was for $10 million.
The point of my post was to show the effect of dilution on share price. The share price went down by more than 50% even though IPIX was putting out good news, including the news that brilacidin was advancing into P3 for OM.
Drugs in development cost money until they make money. Leo's paying on the patent, and the patent has a finite lifespan. Between paying on the patent and paying himself and his several employees, he's eaten almost his entire budget for years, with almost nothing left over for trials (you can read the Q's for yourself and look at the balance sheets). Time is money. Leo has no money. This is a colossal part of our issue.
I feel like a broken record every time I say this.
I'm speaking generally too, not just about Brilacidin.
15yrs is on the far-end of the timeline, which is why I made the point. Total time of development on average for drugs including P3 and final approval if funded properly is closer to 10yrs. http://phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf Sort of highlights the need for a partner, and it's worth a read if you haven't already. It's general.
B-Covid should be progressing SIGNIFICANTLY more rapidly than it is, given the government support programmes in place and the fact that this is during a Pandemic with a global immediate need. EVERYthing is fast-tracked. Except for Brilacidin apparently.
Where the hell is the trial? Since July 2020 it's been '4Q 2020'... now '...in Jan '21' ... and now we have radio silence.
Where is Leo?
Not unusual. Yes, including the time for Polymedix prior to IPIX, B has been in development for 15 years. When there is no urgent need, or there’s been no government focus, vaccines and therapeutics can take decades.
The current spate of mRNA vaccines have been in development for more than 30 years. If it weren’t for a pandemic Big Pharma was probably at least 5 years or more away from consideration of approval. More importantly, last March the Covid task force prioritized vaccines over therapeutics. Lots of money for vaccines, almost none for therapeutics.
Now that there are vaccines, the focus will turn to therapies for those the vaccines have yet to reach. At 1.5 million doses a day, the US is still at least 6 months from herd immunity. Moreover, there is still a month or two lag period to get the next 100 million doses manufactured and distributed.
Therapeutic use for Brilacidin is now becoming urgent as deaths are 4 to 8 weeks behind infections. If B works, it will likely reduce time of infection, tissue damage and recovery time. We should all pray that Covid victims see immediate relief beginning with patient 1. Patient 1 is anticipated by end of next week if the trial begins this week as PRed.
Looking at the IPIX 'progression' of drugs over the course of the 'evolution' of the company is like looking into a window of Geologic-time. 15yrs and nothing seen-through to approval. Nothing seen through a P3 even. Truly astounding. And the financing nightmare has been a common centrepiece throughout.
Hoping (praying) that B for C snaps Leo into reality (or at least the folks around him)... but so far I feel like it's done exactly nothing for his 'time-awareness'.
Can't believe this has been going on for so long...
Quite literally all the difference in the world in terms of investor-availability. No institutional investment option for IPIX and close to zero-vis, with a climbing-daily OS, virtually invisible management, etc etc etc.
You know better than most, that this is an apples/oranges comparo....
We can hope and pray that Leo emerges from hiding with some positive news, but if past is prologue...
Gamestop over $150 this am. Short sellers beware!!!
Funny... this is the question I've literally been asking him for YEARS now, and he has no answer.
I wonder why that is...
This pipeline is phenomenal. Billions and in late stages across board. So the big question. WHY can’t Leo ink a deal. That is the question we all should be asking him daily. The drugs are too powerful on paper to screw this up. IMO.
Fauci on Maddow tonight was super interesting. I can't post the direct link to the show yet (not posted on the site yet), but it's worth a watch when they talk about Therapeutics.
Sounds like they're 'coming', and what was described as 'being desperately needed' sounds identical to what we have with Brilacidin.
Hoping this trial sees the light of day someday sooner than later.
Because Leo thinks he can run a 'billion-dollar company' on a $500k budget.
Nobody ever ran a $150M P3 w $400k in the bank.
Look at the balance sheet history of the company and it'll all make sense.
No funding: no trials/progress. Period.
I'm still very disappointed in Leo in his repeated target date misses. B in the past has received fast track for several applications, yet none materialized. Does anyone know why? Big concern here.
What could possibly be the rationale for the ridiculous holdup here???
ESP when Leo was telling us repeatedly '4Q 2020, for a trial'.
What changed?
And why is it so 'top secret' that nobody is allowed to know anything?
New super-toxic shotgun financing deal to suddenly replace existing financing, that was never PR'd in the first place? That's eyebrow-raising, to say the least...What was that about?
Hope you're right, but this shit is embarrassing, expensive, and grossly unprofessional.
My bet is Dr Kessler will come to the rescue with grants and expedited clinical trials.
This might be worth your time to read through and to get your head around what's actually going on with this company, instead of clinging to the false-narrative related to 'naked-shorting'.
The breakdown and conversion rates have been well documented here recently, so this is so you can read the actual filing firsthand.
Key points outlined:
2.1 Closing.
(a) On the First Closing Date, upon the terms and subject to the conditions set forth herein, the Company agrees to sell, and the Purchasers, severally and not jointly, agree to purchase, an aggregate of 3,053 shares of Preferred Stock, 3,053 Series 1 Warrants and 3,053 Series 2 Warrants for a total purchase price of $3,000,000 (each share being purchased for $982.50). Each Purchaser shall deliver to the Company, via wire transfer or a certified check, immediately available funds equal to its Subscription Amount as set forth on the signature page hereto executed by such Purchaser, and the Company shall deliver to each Purchaser its respective First Closing Shares and Warrants, as determined pursuant to Section 2.2(a), and the Company and each Purchaser shall deliver the other items set forth in Section 2.2 deliverable at the Closing. Upon satisfaction of the covenants and conditions set forth in Sections 2.2 and 2.3, the Closing shall occur at the offices of NMRS or such other location as the parties shall mutually agree. The Company covenants that, if the Purchaser delivers a Notice of Conversion (as defined in the Certificate of Designation) to convert any Closing Shares between the date hereof and 12:00 p.m. (New York City time) on the First Closing Date, the Company shall deliver Conversion Shares subject to such Notice(s) of Conversion to the Purchaser by 4:00 p.m. (New York City time) on the First Closing Date.
(b) On the Second Closing Date, upon the terms and subject to the conditions set forth herein, the Company agrees to sell, and the Purchasers, severally and not jointly, agree to purchase, an aggregate of 2,036 shares of Preferred Stock, 2,036 Series 1 Warrants and 2,036 Series 2 Warrants for a total purchase price of $2,000,000 (each share being purchased for $982.50). Each Purchaser shall deliver to the Company, via wire transfer or a certified check, immediately available funds equal to its Subscription Amount as set forth on the signature page hereto executed by such Purchaser, and the Company shall deliver to each Purchaser its respective Second Closing Shares and Warrants, as determined pursuant to Section 2.2(d), and the Company and each Purchaser shall deliver the other items set forth in Section 2.2 deliverable at the Closing. Upon satisfaction of the covenants and conditions set forth in Sections 2.2 and 2.3, the Closing shall occur at the offices of NMRS or such other location as the parties shall mutually agree. The Company covenants that, if the Purchaser delivers a Notice of Conversion (as defined in the Certificate of Designation) to convert any Closing Shares between the date hereof and 12:00 p.m. (New York City time) on the Second Closing Date, the Company shall deliver Conversion Shares subject to such Notice(s) of Conversion to the Purchaser by 4:00 p.m. (New York City time) on the Second Closing Date.
Also from Article IV:
4.3 Acknowledgment of Dilution. The Company acknowledges that the issuance of the Securities may result in dilution of the outstanding shares of Common Stock, which dilution may be substantial under certain market conditions. The Company further acknowledges that its obligations under the Transaction Documents, including, without limitation, its obligation to issue the Conversion Shares and Warrant Shares pursuant to the Transaction Documents, are unconditional and absolute and not subject to any right of set off, counterclaim, delay or reduction, regardless of the effect of any such dilution or any claim the Company may have against any Purchaser and regardless of the dilutive effect that such issuance may have on the ownership of the other stockholders of the Company.
Do you feel it’s that helpful, given the CTAP // ACTIV programmes? I was under the impression that those programmes were there to function in a similar (broader-even) manner, specifically related to COVID therapeutic/vaccine candidates?
It's certainly good news and will help differentiate brilacidin from other therapies when recruiting patients for the clinical trial. That's my main takeaway.
Will be interesting to see what the market thinks.
Would AlfaSigma need to commence the referred-to 'testing' in order to complete said-testing?
To my knowledge, there is no such 'testing' currently underway.
Can you please provide evidence of such 'testing', to enlighten me? I am unaware of anything that's transpired since the license arrangement was signed, and I believe the IPIX balance sheet would've been updated to reflect the milestones having been met, as there are some fairly relevant and important ones that would've greatly assisted our current financial situation.
I am also heartened that the Alphasigma testing could be completed in this year. If it fails there is no reason for Alphasigma to hide this fact, and if approved, further successes in the overall IBD area could follow. We will know this year, either way.
I tried to pull a copy of the previous Development chart but have no copies. Of course it did not have the COVID and the Alfasigma references, not sure about the rest, though I think the others were there.
I'd LOVE to see that. Your language is interesting though, using 'nervous' for others.
If it's BP, instead of being 'nervous', they could just write a check and own the platform. Lots of leverage, and I'm pretty sure it could be exploited easily.
A merger of some sort would be great for shareholders I'd wager, and we might live long enough to see something actually approved if that happened, which would be great for those in need of B or K.
I'm a critical thinker. It's about thoroughly examining ALL of the 'sides'.
Business decisions don't only focus on the cherry, you have to look at the pros and cons and make educated decisions based upon ALL the facts. Risk assessment and competitive analysis.
I feel like that's not understood by many on this board. Lots of 'emotional gamblers'. That's not why I'm here.
Agreed that there's been 3rd party validation of B, but none of these timelines have been anywhere close to standard. I've checked with friends at other RBL's, who've said they could've run the same tests in literally a week to 1.5wks. It took GMU what, 8mo?
Back to the 'time-is-money' thing... where TF is the trial and why has Leo vaporized?
Soon when that 100M gets added to the existing OS, you won't have an issue with your 'investment' having another -27% shaved off its value, will you? See my point?
Well, I’ve been here long enough to know you play both sides of the equation. Yes, I can see you might be frustrated, but to say that Leo has not done the best he can with where the PPS has been the past 2 years, then you are not giving him any credit. Yes, I’ve said it before that he should have sold more shares prior to the Mako attack so as to have the company properly funded for a period of time. He was a little too frugal back then. I also felt tackling Psoriasis via the Prurisol route was a mistake even though Dr Bertolino was advising and pushing that route.
But all that aside, to have Brilacidin now be front and center with validation via 2 separate independent entities like George Mason University and also Rutgers University, that to me is proof that Brilacidin has some entities worried about their “Gravy Train” being interrupted.
Exactly. The thing I fail to comprehend is: People on here still defend Leo like he's a god/king, and talk down the dilution factor. The dilution IS THE MAJOR FACTOR if you own shares and the fact we've seen close to ZERO verifiable progress in the trial-department! The longer it takes, the more expensive it gets for everyone!
The company refuses to identify contractors, contract specifics with organizations, trial locations, specific trial protocol, financiers, none of it helps with confidence on the shareholder-side of things.
And this is their way of operating. IF they'd managed to pull off the trial-start before YE, then I'd be significantly less concerned. The fact that we got another pivot to include 'pan corona indications' in a recent PR, seemed ludicrous to me. Can you not control your ADD? Let's complete ONE thing here for once in the history of the company?
I get the potential for differentiation within the space and the value-add, but if you can't remember to cancel your $225k office lease, and your solution to not knowing how to set up your voice-mail properly is to just take your phone off the hook, then maybe the complication of clinical trials isn't for you?
The Dec 9th financing is going to add another 100 million shares or more if the current price doesn't hold. It's stunning.
That's almost double the OS alone, when I first got into this stock.
You think that's insignificant?
How many trials were run this past year? How's the return on your 'investment' looking to you so far?
If you just got in, then you're probably doing ok. Anyone holding over the last 4-5yrs is getting their ass kicked, properly.
Dilution IS concerning. If you're unconcerned, then you're not paying attention (or your math might not be in alignment with your investment accumen)
For all the BS talks of Dilution, the OS has increased 24,404,697 shares since September 10, 2020 until 12/31/2020 as per the later updates figures by the transfer agent today. So to say that Leo is not being frugal while issuing shares is just not true. Yes he issued more shares during the first half of 2020, but as we all know, it takes money to get product ready for trials and the right people in place to commence such proceedings. JMHO
It never ceases to amaze me, the 1 step forward and 20 steps-back story with this management.
IBD would ideally be more durable, yes... and I'm pretty sure there's big BP interest on the far side of a successful P2 for IBD, but man... another year down the proverbial drain here, with the OS going from 214M to now 367.9M in 2020. That's insanity.
And what to show for it? A couple million $'s? + crazy dilution for SH's? Some 3rd party pre-clinical tests?
Unreal.
People keep banging the 'progression' gong, but to what end? All this stuff just eats up the clock, and meanwhile, the only people profiting from this are Leo and the loansharks. (anyone dug into his connection with the financiers?) Shareholders continue to get jacked, zero products with any sort of approval, no trials... nothing.
I've been part of class-actions for significantly less than this BS. Shocking to me that nobody's gone after the company besides Mako.
And you nailed it earlier, with your mention of 'shoulda got out with the Mako warning'. Right?
Wouldn't be the worst thing in the world. 120 patient oral phase 2 would be easy and cheap. Much bigger and durable market than COVID.
Clearly, a Thorough QT study with brilacidin showing no major QTc prolongation would go a long way to set everyone at ease. Such a study has not been done yet. However, we were surprised to find a trial of brilacidin ORAL RINSE listed on clinicaltrials.gov. Interestingly, patients with EKG abnormalities, hypertension, and QT prolongation are specifically excluded from participation in this trial, although brilacidin is only given topically.
What do we really know about brilacidin / PMX-30063? Given the dearth of published information and the total lack of peer-reviewed publications, the answer is: Really not much. Abstracts and presentations by PolyMedix and Cellceutix, the new owner of brilacidin, from various conferences are uniformly selective, redacted and incomplete. [6,7],
Given the COVID19 moderate-to-severe indication, and use as a lifesaving drug, I wonder about the priority given as such, and the use of hypertensive moderating interventions in conjunction with B? (thiazide?) We know little of the PK on the iv side since trial-numbers have been small. Pharmacodynamics, similar.
A conversation with someone close to the subject mentioned that there wasn't a hypertensive concern related to this indication.
Look back to 2015 for a potential explanation as to why there's been so little interest in brilacidin from big pharma, or any pharma. Brilacidin – QIDP Drug At a Critical Juncture (July 10, 2015). The author covers the good points and the hazards of the drug.
Read the full article to understand the thinking of this person and whether they are credible. If you don't have time for that, the 3 paragraphs below contain the most important hazard material imo.
Quote: More important and of concern is the fact that numbness and tingling are still extremely frequent AEs (58-74%) in the Phase 2b trial despite the dose reduction. The syndrome has been described as “paresthesias, usually beginning in the oral area, and often with subsequent extension to one or more of the following areas: face, scalp, extremities, upper thorax, and/or perineum (groin and buttocks)”; the company refers to it as an ‘ion channel effect’ of short duration and reversible. [3]
In the context of the blood pressure changes observed in Phases 1 and 2, this ‘ion channel effect’ may be anything but trivial. Electrophysiologic studies on human cell lines published in abstract form found that even low concentrations of brilacidin (1µM) block ion channels to a significant degree: 43.2% (ASIC1a), 56.3% (hNav1.7) and 45.8% (hKv1.6).[4] In case you are interested, ASIC1a stands for acid-sensing ion channel, and hNav1.7 and hKv1.for the sodium and the potassium channel, respectively.
This Kv1.6 channel is expressed not only in neurons, but also in cardiac and other muscle tissue where it affects membrane potential and cellular response to stimuli [5]. While ion-channel blockers are an area of considerable interest for drug therapy, we are not convinced such off-target effects are desirable for an antibiotic. Even if it is a QIDP drug.
It's important to note that the author specifies that some of the hazards exist at concentrations of brilacidin as low as 1µM. For context, much of the RBL testing was based on cells exposed to 10X that concentration continuously for a period >24 hours.
I’m 100% with OG on this one. The development of other T options has EVERYTHING to do with Leo et.al. This is about market-share, the ability to develop and DELIVER a product that can demonstrate results. The longer it takes the less its worth, and the more is costs the company (shareholders) Period.
Addressing a pandemic and the immediate needs of a global population is the target with very real potential consequences for the company, if they don’t get it right (reference- the balance sheet)
IPIX is under-capitalized (that’s being incredibly generous about it).
Having little/no disposable cash is what puts you in a business environment where ‘nothing happens’. You’re stuck in the doldrums. This is why we’ve run statistically insignificant trials that never attract any partnership/M&A interest. This is why we have indications frozen in time, approved for P3, but go nowhere. It’s why Kevetrin is mothballed in a basement somewhere.
My guess is you don’t actually know who ‘IPIX’s largest investor is’. Leo may be the majority shareholder, but he gifted himself those shares, on top of paying himself $465k/yr. Giving yourself something as opposed to ‘investing in something’ are two distinctly different economic positions.
(Wikipedia: An investor is a person that allocates capital with the expectation of a future financial return (profit) or to gain an advantage (interest).[1][2] Through this allocated capital most of the time the investor purchases some species of property. [3]Types of investments include equity, debt securities, real estate, infrastructure,currency, commodity, token, derivatives such as put and call options, futures, forwards, etc. This definition makes no distinction between the investors in the primary and secondary markets. That is, someone who provides a business with capital and someone who buys a stock are both investors. An investor who owns a stock is a shareholder.)
Nobody knows WTF is going on with Leo & co, and until he either re-emerges from wherever he is, or we get some notice of him being elsewhere or something having been developed, the rest of the planet will continue to progress with respect to C-19 concerns.
The clock isn’t waiting for IPIX, and as a shareholder, with each passing day that the financing arrangement in-place continues to dilute the SP, the value of what you’re holding (if you own shares) will continue to diminish.
So you and everyone else should be telling Leo to get going and to get some info out there.
If you want more people to learn about the ‘miracle drug, Brilacidin’, then the more publicity the company has, the more eyeballs are on the company, availing themselves to potential investment here and slowing dilution.
You’re right in that doctors don’t prescribe drugs ‘Willy nilly’. They also don’t prescribe anything with only some basic pre-clinical data either, which should be lighting a fire under every single shareholder and LEO, to get this shit show moving. (Google: ‘the Time Value of Money’)
We’ve seen companies develop vaccines from concept through rollout in less than a year. In that same i]year now, IPIX has had a 3rd party run a few tests... You want me to believe that we’re ‘doing great’? As others here seem to conclude? Where’s the trial Leo wouldn’t shut up about, to ‘start in Q4’.
If you’re making that announcement, then you have actionable intel related to timelines and an ability to make it happen usually... otherwise why would you say that?
If not, then that’s an intentionally misleading statement which would mean that the only ‘trial’ Leo would logically see would be in front of a jury of his peers, due to the SEC violation.
The development of other therapeutic options have nothing to do with Leo and news about Brilacidin.
We're not in a race with anybody. Leo should continue to execute his plan for the development of B-COVID in a way that effectively demonstrates "B's" power. He should dot all the iiii's and cross all the ttttt's without regard to petulant investors.
I'm glad IPIX's largest investor seemingly pays no attention to the comments on this board.
How asinine it is to believe that Leo is just holding news for the sake of holding news.
Doctors don't just prescribe drugs willy-nilly. They look at the data behind a drug to determine its appropriateness for their patients.
With all the talk of BP skulduggery, political manipulation and you suggest Leo should be spilling his guts of everything he knows whenever he knows it
Your reference to the PFE deal may actually slightly misguided. OWS was involved indirectly I think with some planning, but the backdoor approval and deal was negotiated and executed by ATI. It was significantly faster I think they decided, than trying to deal with the red-tape associated with OWS. They could also disclose that 'no funds were provided directly by the government' (they were, but it was indirectly, through a back-channel).
I don't think it was politics as much as PFE fast-tracking large financing without OWS oversight.
'...as well as BP politics (PFE holding back announcement until after the election...then denying an OWS assistance to the tune of $1.9B), the FDA slapping additional time for coming out party for PFE's vaccine...until after the election.'
I’d be looking for an EUA filing pending a successful P2. With an EUA in place and a running P3 simultaneously, I think we could keep things moving.
I thought we’d seen this from a number of other companies over the course of the last year.
But... at this point I’m questioning whether a trial is coming or not. I can’t imagine it wouldn’t be, but we’re well-past Leo’s announced projected start.
Funding Leo’s payroll eats into available cash at a staggering rate, since the company isn’t funded adequately... which could be a possible explanation for the otherwise unexplained cash-raise we got prior to the holidays. Otherwise, what? More sites? More manufacturing?
This was also what CTAP and ACTIV were in place for. To help companies like IPIX move through the hurdles, setup and fund trials etc. Yet we’ve heard nothing about either of these or the company’s involvement with them. Why?
We need an update. This is non-standard communication during a pandemic, with a company advertising having the ‘gold standard of therapeutic treatment’’, while thousands die per day. What is happening?
Rd, guess we disagree. FDA won't give an approval with just 120 in the test group. No P 3, no approval. But if the P 2b is great, I don't think money or pps will be an issue. On the other hand, since we have not seen any real indications on what the study will entail, maybe we are both fos on this one.
Slight correction: “all without financial benefit’.... to IPIX shareholders
I don’t think IPIX’s track record on P2 trials supports your assertion: “If a SUCCESS...money, grants even partnerships...lots of money will flow...because the efficacy as a therapeutic will have been confirmed. Yippie!!!”
Consider the following: brilacidin for ABSSSI P2 was a “success”, brilacidin for OM P2 was a “success”, kevetrin for ovarian cancer P2 was a “success”, and prurisol for chronic plaque psoriasis was a “success”.
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