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I'm 100% with you.
I posted a few posts-back, the charts from the PrePrint that were identical to the Peer Review which showed the same lack of efficacy, unless I'm also reading them wrong?
I don't think many (anyone?) from this board has actually scrutinized either doc to the extent required? I share your concern; having also re-read both docs to the letter.
Further troubling is the fact that Leo has chosen to communicate like a greasy used-car salesman about literally everything. So nobody actually knows WTF is going on or when or what anything means.
Intentional obfuscation
I just re-read this PR, which may help to shed some light?
http://www.ipharminc.com/press-release/2020/6/11/innovation-pharmaceuticals-collaborating-with-regional-biocontainment-lab-on-grant-application-to-research-brilacidin-as-a-pan-coronavirus-therapeutic
I wondered about that whole 'pre-incubation-thing' too.
Not like you're being pre-incubated with Brilacidin before you go to the store to pick up your CoronaVirus...
Like I said in a post earlier today: This whole thing is starting to smell a little like a shit-sandwich.
Although, I can't understand why the FDA would grant FTD if there wasn't something there?
I also can't understand why they'd clear IPIX for a human-trial if they didn't see something there to begin with?
I don't think Leo's the brightest bulb in the barn, but surely he wouldn't spend what's literally the only cash he has in a hail-mary that's doomed to failure and will sink the company if the trial burns?
I ran this by someone at another RBL and he said the results looked solid, so maybe there's something there?
Does it make you hopping-mad to be invested in a company that can't communicate facts clearly, and forces us to do DEEP DD just to try to figure out WTF is actually going on? Cuz it makes me irritated as hell...
FWIW, Weston and Harness were mentioned in the preprint 'author/contributor' section at the top. If you hover over their names, their affiliations are highlighted.
Nothing beyond that, but I think if you're reading through it and looking at references (as I was), I hovered and checked the qualifications of contributors.
Copied/pasted below from the PrePrint:
-Allison Bakovic
1National Center for Biodefense and Infectious Diseases, George Mason University, Manassas, Virginia, 20110, USA
-Kenneth Risner
1National Center for Biodefense and Infectious Diseases, George Mason University, Manassas, Virginia, 20110, USA
-Nishank Bhalla
1National Center for Biodefense and Infectious Diseases, George Mason University, Manassas, Virginia, 20110, USA
-Farhang Alem
1National Center for Biodefense and Infectious Diseases, George Mason University, Manassas, Virginia, 20110, USA
-Theresa L. Chang
2Public Health Research Institute, Rutgers, the State University of New Jersey, New Jersey Medical School, Newark, New Jersey, 07103, USA
-Warren Weston
3Innovation Pharmaceuticals Inc., Wakefield, Massachusetts, 01880, USA
-Jane A. Harness
3Innovation Pharmaceuticals Inc., Wakefield, Massachusetts, 01880, USA
-Aarthi Narayanan
1National Center for Biodefense and Infectious Diseases, George Mason University, Manassas, Virginia, 20110, USA
AUTHOR INFORMATION
Allison Bakovic1, Kenneth Risner1, Nishank Bhalla1, Farhang Alem1, Theresa L. Chang2, Warren Weston3, Jane A. Harness3 and Aarthi Narayanan1*
1National Center for Biodefense and Infectious Diseases, George Mason University, Manassas, Virginia, 20110, USA
2Public Health Research Institute, Rutgers, the State University of New Jersey, New Jersey Medical School, Newark, New Jersey, 07103, USA
3Innovation Pharmaceuticals Inc., Wakefield, Massachusetts, 01880, USA
Olden...
So i just went back over the chart and came to the same conclusion.
I thought I remembered from the Pre-Print that the opposite numbers were represented for Brilacidin from identical testing (I believe I was mistaken; having taken another look).
Below is the pre-print reference progression (hard to see with the small font)
Figure 2A.
Brilacidin inhibits SARS-CoV-2 replication (Vero cells)
(A) Vero cells were pretreated for 2h with 2 or 10µM brilacidin, infected with SARS-CoV-2 non-directly at MOI 0.1 for 1h, and post-treated with media containing brilacidin as described in Materials and Methods. At 16hpi, viral supernatants were evaluated by plaque assay as described in Materials and Methods.
Figure 2B, 2C. Brilacidin appears to impact entry of SARS-CoV-2 (Vero cells)
(B) Brilacidin was measured at 10 and 20µM for neutralization activity against a luciferase-expressing pseudotyped virus (rVSV) containing the SARS-CoV-2 spike protein using luciferase assay in Vero cells at 24hpt as described in Materials and Methods and compared to neutralization activity of hydroxychloroquine. (C) Vero cells were treated with 10 or 20µM brilacidin for neutralization activity against SARS-CoV-2 rVSV, and cells imaged and quantified using fluorescent microscopy and FITC surface intensity plots at 1 and 4hpt as described in Materials and Methods.
Graphs are representative of one independent experiment performed in technical triplicates (n=3). Brl indicates brilacidin. **p<0.0021, ***p<0.0002, ****p<0.0001.
Figure 2D, 2E.
Brilacidin appears to disrupt the integrity of the SARS-CoV-2 virion
(D) Vero cells were pre-treated for 2h with 10µM brilacidin. SARS-CoV-2 was diluted to MOI 0.1 in culture media containing brilacidin and incubated for 1h. Viral inoculum containing inhibitor was added to cells for 1h for a direct infection, and post-treated with media containing brilacidin as described in Materials and Methods. At 24 hpi, viral supernatants were evaluated by plaque assay as described in Materials and Methods.
(E) Vero cells were pretreated for 2h with 10µM brilacidin or media only (indicated as [entry]). SARS-CoV-2 was diluted to MOI 0.1 in culture media containing 10µM brilacidin and incubated for 1h. Brilacidin-treated viral inoculum was added to cells for 1h for a direct infection, and replaced with inhibitor containing media or media only (indicated as [entry]) as described in Materials and Methods. At 24hpi, viral supernatants were evaluated by plaque assay as described in Materials and Methods.
Graphs are representative of one independent experiment performed in technical triplicates (n=3). **p<0.0021, ****p<0.0001.
Figure 3.
Brilacidin exhibits potent inhibition of SARS-CoV-2 in a human cell line (Calu-3 cells)
(A) Calu-3 cells were pretreated for 2h with 10 or 20µM brilacidin and infected with SARS-CoV-2 at MOI 0.1 non-directly or (B) directly with brilacidin for 1h as described in Materials and Methods. Cells were post-treated with media containing brilacidin, and at 24hpi viral supernatants were evaluated by plaque assay as described in Materials and Methods. (C) Calu-3 cells were pretreated for 2h with 10µM of brilacidin, infected with SARS-CoV-2 at MOI of 0.1, 0.05, 0.01, or 0.001 directly with brilacidin at 10µM for 1h, and post-treated with media containing brilacidin as described in Materials and Methods. At 24hpi, viral supernatants were evaluated by plaque assay as described in Materials and Methods. Statistical analyses for varying MOI was determined using Two-Way ANOVA with Sidak’s multiple comparisons test. Significance for all other graphs were determined as described in Materials and Methods. Graphs are representative of one independent experiment performed in technical triplicates (n=3). **p<0.0021, ***p<0.0002, ****p<0.0001, ns = not significant.
Figure 5A.
Brilacidin against SARS-CoV-2 in combination with favipiravir (Calu-3 cells)
(A) Calu-3 cells were pretreated for 2h with media alone or media containing brilacidin at 10µM (for synergy treatments). Cells were infected with SARS-CoV-2 at MOI 0.05 directly with brilacidin at 10µM (for synergy treatments) or SARS-CoV-2 incubated in media alone (for favipiravir treatment alone). After 1h, post-treatment with favipiravir (B) alone, or mixed with 10µM brilacidin, were added to cells at 1 or 2.5µM concentrations. At 24hpi, viral supernatants were evaluated by plaque assay as described in Materials and Methods. Graphs are representative of one independent experiment performed in technical triplicates (n=3). Brl indicates brilacidin, Favi indicates favipiravir. Statistical analyses for synergy vs. individual control treatments was determined using Unpaired Two-Tailed Student’s t-test. Significance against DMSO was determined as described in Materials and Methods. **p<0.0021, ****p<0.0001, ns = not significant.
Figure 5B, 5C.
Brilacidin against SARS-CoV-2 in combination with remdesivir (Calu-3 cells)
(B) Calu-3 cells were pretreated for 2h with media alone or media containing brilacidin at 2.5 or 10µM (for synergy treatments). Cells were infected with SARS-CoV-2 at MOI 0.05 directly with brilacidin at 2.5 or 10µM (for synergy treatments) or SARS-CoV-2 incubated in media alone (for remdesivir treatment alone). After 1h, post-treatment with remdesivir alone, or mixed with 10µM (B) or 2.5µM (C) brilacidin, were added to cells at 1 or 2.5µM concentrations. At 24hpi, viral supernatants were evaluated by plaque assay as described in Materials and Methods. Graphs are representative of one independent experiment performed in technical triplicates (n=3). Brl indicates brilacidin, Rem indicates remdesivir. Statistical analyses for synergy vs. individual control treatments was determined using Unpaired Two-Tailed Student’s t-test. Significance against DMSO was determined as described in Materials and Methods. *p<0.0332, **p<0.0021, ****p<0.0001.
...Recently released in vitro data showed Brilacidin exhibited a potent inhibitory effect on SARS-CoV-2, the novel coronavirus responsible for COVID-19, in a human lung epithelial cell line—reducing viral load by 95 percent and 97 percent at two efficacious concentrations tested, compared to control (DMSO).
Cure for what? What has Brilacidin been proven to 'cure' specifically? Have we got an approval for something I'm unaware of?
Value is assigned based on what the market supports.
How many signed and executed deals for anything related to any indication/molecule that IPIX has, do we have?
To-date we know that Brilacidin shows favourable activity in a petri dish and in assays against SARS CoV-2. Period. We know nothing more. It is definitively not a cure for anything.
See here: https://www.mdpi.com/1999-4915/13/2/271#cite
BP acquires what's been either proven or de-risked to make their investment worthwhile... usually to fill holes in existing portfolios with a management team in place familiar with the space to facilitate further development and commercialization, and/or complementary with existing pipeline concerns.
Think of BioTech as the 'R&D arm' for BP.
To-date, what has IPIX sold to BP?
M&A's aren't classically about 'deals' but rather about market position. This is why I look for a more favourable valuation with an IPIX/BP interface with a BP that's not currently deeply engaged in a channel related to existing IPIX IP.
Keep in mind too, that the numbers you're associating with a 'buyout' aren't reflective of what a fully-developed and commercialized product would bring, expressed as net-revenue annually. Further, IPIX has never executed as much as a P3 trial, has never taken a drug to commercialization, etc. Leo has exactly zero experience doing anything past a P2.
Additionally, if you're thinking that IPIX can fully develop their pipeline and your 'investment' with the company has been made accordingly, then based on past performance and the insanely elastic timeline to-date, I'd anticipate an additional 10-15yrs to see the first NDA granted by the FDA for an IPIX product. P3's take on average 2yrs min, and cost ~$100M+, which is why IPIX has never run one.
COVID is the fastest-track to commercialization we've seen. It's a once-in-a-lifetime opportunity for the company as well as its shareholders. If Leo blows this, it could be lights-out.
So you're trying to assign a value for something that doesn't correlate with what would be on the table for an M&A valuation.
That is MY honest opinion based on the SCIENCE and the GOING rate for similar medications that are band-aids and NOT cures as is Brilacidin !!
I think most would like to see a big partnership and see Leo hand the reigns to a seasoned biotech CEO.
I’ve put this on his table actually over the last several years, and Leo never wants to talk about it.
This makes me feel like something nefarious is going on.
Same guy (John Miller), 2 different entities. Leo tries to shield him as long as possible (until the 13G is required), and then they (Leviston) sold-down below the reporting threshold (several times based on filings) to remain anonymous. I’m expecting the same this time, and esp since the LP was literally just formed days-prior-to.
I wonder why this would be? I know why I would do it.
This whole thing stinks like shit honestly. Lies about trial ‘starts’, zero explanation about why the ‘emergency $3M’ was required, to the tune of diluting shareholders by what, 30% in a matter of a couple months? That’s significant, and I’d consider it a ‘Material Event’ requiring disclosure.
This is around the point where a 3rd party Scientific Audit would more than make sense, which was recommended 8mo back by a friend who’s at another RBL.
Something’s not right here.
...and yeah, John Miller has made what... like $10M+ off this arrangement in a matter of less than a year. I want to know how much gets kicked back to Leo.
Hmmmm . . . maybe we pool some money and talk to this guy about getting a piece of their next IPIX financing. They made more in 2 months on IPIX than I made in 10+ years!
no
Would this type of agreement cause radio silence from the company?
NO. That's 100% not how it works.
It's all explained here: https://www.sec.gov/Archives/edgar/data/1355250/000147793220007184/ipix_ex101.htm
This is what I tried to explain to you a week or so ago when you told me 'this smells like BS'.
Start reading.
Aspire converts, Miller buys.
Hmm... so many questions arise from this discovery.
I wonder if John Miller made so much from the round with Leviston that he could swing this on his own? To protect himself personally, he incorporated as a LP in Delaware (this is what I would do) and then cash-grabbed the deal with Leo, since Leo was in a corner?
The thing that seems super strange is: Why did Leo 'suddenly' need $3M out of a deal that sidelined Aspire and was massively dilutive?
...and this John Miller guy just happened to be there to sail-in to save the day?
Further, there was no PR reflective of the event. That strikes me as strange; being what I'd consider a 'material event' based solely on the amount of dilution it subjected shareholders to... not to mention the crazy price-action effect it has over time.
What I'm wondering now is: IF this was the source of the 'deal', does this mean the conversion has run its course? If so, we should see favourable price-action in the coming days (hopefully) without the downward pressure (until the 2nd offering at least).
If I were in this position, I'd hold (John Miller), if in fact IPIX is on the verge of actually running a trial. Unencumbered SP action would make him (and everyone else) a fair bit of money I'd think, if these pieces line up.
Am I reading this correctly?
I'm curious about who's holding what at this point.
Also, I'd be wondering about a Hostile at some point? I know Leo's pretty hedged, but...
To your question: Maybe the timing wasn't right previously for them to hold and the sure-thing was to convert and unload, but now the timeline might make more sense. That's how I'd likely play it. They have access to info that we peasants don't have.
Spitballin':
Both Leviston and Kips Bay filed their 13Gs the same day as or shortly before the Company made an SEC filing that showed (an S3 in the Leviston case) or will show (10Q on Tuesday for KB) a current outstanding count that exposes their holdings to be 5%+.
Investors like this DO NOT want their trading activity to be revealed...it can work against them in the hands of other "investors". So Leviston had to file the 13G but as soon as they could swing it they sold down below 5%, filed the 13G/A and escaped their filing obligation.
If that's true we can expect KB to do the same thing, as you suggest. The question is: Why would KB hold so many shares when they flip for a living?
Just based on the Leviston activity.
I could be completely off-base, and I guess it could be different given the 'trial pending'...?
https://www.sec.gov/cgi-bin/browse-edgar?CIK=0001731368&action=getcompany
Perhaps we were too far off before, for them to want to hang about for any period of time when they had a sure-thing with the conversion and sales?
Why?
MFO // Partner. I don't know how much it matters at this point?
Good points though. Thank you. I was feeling like you'd give it a proper read-through.
This whole situation smells a little funny to me.
"Thinking KB is/was the current MFO"
I thought so too. (Except that there's nothing in the documents to suggest that the Purchaser is an MFO).
So is it the Purchaser in the Preferred Agreement? Some random thoughts...
From the very first line of the Agreement:
"This Securities Purchase Agreement (this “Agreement”) is dated as of December 9, 2020, between Innovation Pharmaceuticals Inc., a Nevada corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively, the “Purchasers”). The Company agrees that in this case, there will be only one Purchaser."
I guess the "only one Purchaser" could be the Partnership itself, although the Partnership by definition would have to have more than one partner.
"The Company agrees that in this case, there will be only one Purchaser" is an unusual note that wouldn't seem to be required. The "in this case" phrase reminds me that there were TWO investors in the earlier preferred agreement that WAS with an mfo. Does that suggest that the current investor(s) may have been involved in the earlier investment?
The consistency between the terms of the earlier preferred agreement and the current deal (structure AND pricing) suggests that the same party or parties might be involved.
Leviston hung out around the filing threshold for 5 days from filing to filing.
https://www.sec.gov/cgi-bin/browse-edgar?CIK=0001731368&action=getcompany
Can't imagine why this time it would be much different?
Who knows?
Unload on Tuesday....I don't think so is that what you think with the 20m shares?
see my subsequent post. Leviston and Kips Bay are the same John Miller guy...
Looking for a 13G/A filing on Tuesday as he unloads.
Looks like John Miller was the Leviston Resources guy as well as the Kips Bay guy:
Leviston Filing: https://www.sec.gov/Archives/edgar/data/1355250/000121390020017195/ea124065-13gleviston_innova.htm
Scroll to bottom.
Signed: J. Miller
Date: July 10, 2020
Kips Bay Filing:
https://www.sec.gov/Archives/edgar/data/0001845716/000121390021008496/ea135337-sc13gkipsbay_inn.htm
Scroll to bottom.
Signed: By: /s/ John Miller
Name/Title: John Miller/ VP of Finance
Date: February 11, 2021
I'm calling Kips the MFO, and looking for a 13G/A filing imminently.
Leviston had 5.2% @ 16,665,734 shares of Common Stock Class A
June 29, 2020
https://www.sec.gov/Archives/edgar/data/1355250/000121390020017195/ea124065-13gleviston_innova.htm
Thinking KB is/was the current MFO
Over 5% ownership is pretty significant when you consider how much Leo and Menon control. I wonder when they made their move?
...yes, I can see how wanting clarification of a statement by the company that made it, would be considered 'bullshit' as you say...
#ridiculous
Classic bullshit sunny.
SO, when you're going to go to the grocery store for supplies, do you tell your wife: 'Hey, I'm scheduled to go to the store next week'?
or... do you say: 'hey, I'm going to the grocery now'? Or 'I went to the store'? (Past perfect tense), or 'I'm going shopping on tuesday' ?
IPIX running a clinical trial after missing 2 previous 'deadlines' isn't like making an appointment to have the oil changed in your car. Not with a 'multi-national' 120 patient, multi-site trial attempt (during a pandemic)
This is strictly non-standard corporate communication, and it's non-definitive in this case, given the company history related to execution.
I'm playing the sceptic until there's actual demonstrable proof. (a confirmation PR, an SEC filing, etc)
Who said it did not start as per Leo’s PR stating that it was slated to begin last week?
No idea.
I wanted to see what happened after another week or two, and still nothing.
What's the missing ingredient to actually initiate or start P2?
We have the funds from the financing arrangements
We have the manufactured drug (per Nov 16th PR)
We have an active IND (per Dec 21st PR)
B given fast track status (per Jan 14th PR)
We have sites (per Dec 21st PR)
There are still many people hospitalized with Covid around the world
Is there a missing ingredient? It would seem leadership is the missing ingredient, however the prerequisite steps prior to a P2 seem to be covered. Something is just not adding up
Last time it was Leviston Resources
7-17-2020
https://www.sec.gov/Archives/edgar/data/1355250/000121390020017520/0001213900-20-017520-index.htm
Doesn't seem that 'unusual', given Leo's mechanisms of financing employed.
Their position was closed shortly thereafter.
Not sure, but it makes the 10Q more interesting than usual.
Let the pie in the sky interpretations begin.
...wondering if there's a possiblity this was the MFO, hanging onto shares...
I see more validation and belief in the company in direct contrast to a lot of the bullshit that's posted here daily.
Leo never ceases to upset the apple cart. The wokes would refer to this as "disrupter".
I'm unconvinced it's relevant to anything IPIX-related.
IPIX doesn't exist in the public-knowledge space. Zero reach anywhere... literally. Hopefully it'll change sooner than later.
Hopefully a trial will happen sooner than later too, while we're at it...?
I'm not sure how much it'll matter though if much more time goes by?
This is why we're flagging this week:
https://www.israel21c.org/has-israel-just-found-the-cure-for-covid/
While everyone here is talking about Remdesivir, the bar is getting much higher very quickly. Remdesivir is not our competition.
Sure, but they might want to get the product into a living breathing human first. Otherwise FDA will just laugh...
Literally everything is hinged on this trial...
J&J filed for emergency use for their covid19 vaccine. Coudldn't IPIX file for emergency use of Brilacidin?
I'd be keen to see a merger of sorts.
I know Leo is emotionally attached to progressing Kevetrin, but relatively nothing's happened related to its development, so he'd likely want to see that incorporated into any valuation if at all possible (reaching).
Rolling a buyout into just the single COVID indication seems a little bananas, but you never know.
With IBD undeveloped too, I have a hard time seeing him walking away completely, especially with Bill in the room... but perhaps that's additional negotiating leverage at the table?
Who knows.
All I know is that fiscally, nothing's happened on the + side in 15yrs of this shitshow, and it's now or never, as far as I can see.
I think that is what will likely happen if the COVID trial succeeds. Barring some juicy goverment money, partnership or sale of all IV indications seems most likely to me.
Or if they're willing to pony up $3B for the whole enchilada I'm sure he'd go for it this side of June.
Get everyone out at $7.00 by summer? Yes please.
An acquisition would help stop the bleeding.
Leo's what, 62?
This shit can't keep going on forever. He could cash out and let someone else actually develop this platform on a less-glacial timeline, with actual dollars.
Looking for a BP to take over to get this through P3 and to get this into humans. Wondering if this is why all this vague and nonsensical communication is happening? (They'd want the publicity)
Plug that hole amigo!
Outstanding Share Count YTD:
30 Jan 2020 OS 214M
30 Apr 2020 OS 267,408,840
31 May 2020 OS 296,688,311
30 June 2020 OS 328,317,492
14 Sept 2020 OS 343,579,992
16 nov 2020 OS 355,957,332
30 Nov 2020 OS 357,616,780
31 Dec 2020 OS 367,984,689
31 Jan 2021 OS 390,861,713
Not sure why you'd think that, when this is what the recent history of 'progression' PR's looks like:
1. December 26, 2019
Innovation Pharmaceuticals: Patient Screening for Phase 1 Trial of Oral Brilacidin in Ulcerative Colitis Program On Track for Early January
http://www.ipharminc.com/press-release/2019/12/26/innovation-pharmaceuticals-patient-screening-for-phase-1-trial-of-oral-brilacidin-in-ulcerative-colitis-program-on-track-for-early-january
2. January 16, 2020
Innovation Pharmaceuticals Announces Dosing of First Cohort in Phase 1 Trial of Oral Brilacidin in Ulcerative Colitis Program; Topline Results Anticipated Early Q1 2020
http://www.ipharminc.com/press-release/2020/1/16/innovation-pharmaceuticals-announces-dosing-of-first-cohort-in-phase-1-trial-of-oral-brilacidin-in-ulcerative-colitis-program-topline-results-anticipated-early-q1-2020
So now suddenly, the PR King of BioTech is going to go silent about the initiation details concerning a trial?
As far as I’m concerned, it started last week as per the previous PR stated. Leo might be waiting to PR trial filled next.... But to each their own beliefs...
Can you say: START THE TRIAL ALREADY....?
Can you say GLOBAL E.U.A
Super interesting article and case presentation here:
https://www.npr.org/sections/goatsandsoda/2021/02/05/964447070/where-did-the-coronavirus-variants-come-from?utm_source=facebook.com&utm_campaign=npr&utm_term=nprnews&utm_medium=social&fbclid=IwAR3EPezkAUROrIN2gWS7eOSwa3LngSWxR4Yt3X6BzLakIDabr8kC_AeWJE0
IF this isn't a screaming justification for getting Brilacidin into humans, I don't know what is...?
Where the hell is the trial, Leo?
Yep, THEN the P/E ratio could actually finally be applied in some way...
Oh, that $4B was just on the granting of EUA. If we log $1.8B in revenue then not only will we get what you posted below but we will get forward credit on Brilacidin for UC, OM and Kevetrin as well. This company with billions in revenue will result in nutty stock prices.
November 16, 2020
Innovation Pharmaceuticals Announces Overseas Regulatory Filing Submitted For COVID-19 Clinical Study
Brilacidin
· New in vitro data also demonstrates Brilacidin’s anti-SARS-CoV-2 potency is unlikely to be impacted by mutations in different strains of the virus
WAKEFIELD, MA – November 16, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, announces today that an overseas Clinical Trial Application (CTA) has been submitted to the governing health agency, with a U.S. Investigational New Drug (IND) application also to be submitted this week to the FDA. Both these submissions are part of final preparations for the Company’s multinational Phase 2 clinical trial of Brilacidin for COVID-19, which is on track to commence in 2020 upon gaining required approvals.
The randomized, double-blind, placebo-controlled, multi-center study is anticipated to enroll 120 hospitalized patients with COVID-19. Sufficient Brilacidin intravenous (IV) drug product has been manufactured to complete this trial, and potentially future COVID-19 trials, providing the Company with added flexibility as it develops Brilacidin for the treatment of COVID-19.
In other important news, the Company has been informed by researchers at George Mason University’s Regional Biocontainment Laboratory that new in vitro testing showed Brilacidin exerted similarly potent inhibition against two strains of SARS-CoV-2, the novel coronavirus responsible for COVID-19. These data suggest Brilacidin would likely not be susceptible to resistance developing due to SARS-CoV-2 mutations, unlike many other vaccines and antivirals currently in use and in development.
“Due to the rapid worldwide spread of the COVID-19 pandemic, the need for novel therapeutics to help control this disease has only increased,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “While we all hope for the expedient arrival of safe and effective COVID-19 vaccines, which is one part of the solution, the need for better therapeutics to treat this disease, including its different strains, also remains essential. Vaccines and therapeutics both will play integral roles in addressing the current COVID-19 pandemic and possible future viral pandemics. We are excited by Brilacidin’s potential to treat SARS-CoV-2 and look forward to the start of our upcoming clinical trial, as we continue to advance Brilacidin in the global fight against COVID-19.”
Not sure why everyone is so bent out of shape on the start date it's only a week late....I assume they have a lot on their plate. If they were behind months then I would understand....just be patient.
I always feel like more info is better than less info (unless you're facing a firing squad).
Investors, be they retail or institutional, are looking for concrete details to make educated investment strategies around.
All these deliberately confusing PR's, vague timelines etc, don't allow for investment timelines or much of anything to be based upon. I've tried this for years, for both personal use as well as clients and funds. This stuff with Leo is just pure nonsense. The folks who dismiss it seem largely to be emotional-investors and not serious folks with any understanding of business or finance.
Concrete info is necessary. I hate to say it's 'what the market needs' because I feel pretty strongly that nobody really even knows who IPIX is or what they're about. They'll know more following trial results (hopefully positive), at which point we hope to see an EUA and simultaneous P3, partnership/M&A etc... many things to hopefully come from this. But first... trial.
I don't feel like it's Leo's 'default' to not release info either, but rather someone else who's sitting on his shoulder; mentioned by another poster on here. It's problematic.
The recent volume is encouraging, but the approaching further massively-diluting event-date with the MFO for the 2nd closing will be upon us before we know it.
Time matters... I'd like to see this get moving.
Additionally, people keep saying: 'Leo keeps selling shares/raising funds'. 'LEO' isn't doing anything of the sort. The MFO is converting preferred. They sell into the market when they want, not when Leo compels them. Leo also is restricted from borrowing elsewhere, so he's locked into this deal until its either run its course or other action is taken. So time matters, indeed.
https://www.sec.gov/Archives/edgar/data/1355250/000147793220007184/ipix_ex101.htm
2.3 Closing Conditions.
(iv) the Company shall have suspended sales under the Aspire Purchase Agreement and shall have delivered evidence thereof that is satisfactory to the Purchasers in their sole discretion;
Additionally, the current agreement with the MFO related to Leo's ability to source funding elsewhere:
4.17 No Indebtedness for 9 Months.
From the date hereof until the nine (9) month anniversary of the Closing Date, the Company shall not create, incur, assume or guarantee any indebtedness for borrowed money of any kind (other than trade payables and accrued expenses incurred in the ordinary course of business consistent with past practice), or amend or refinance any existing indebtedness for borrowed money of any kind, including, without limitation, a guarantee on or with respect to any of its property or assets now owned or hereafter acquired or any interest therein or any income or profits therefrom; provided, however, that the prohibition in this Section 4.17 shall remain effective and applicable following the nine (9) month anniversary of the Closing Date if (i) the 30-day average dollar trading volume of the Common Stock (as reported as reported by Bloomberg L.P.) is less than $20,000 per Trading Day and (ii) any Closing Shares remain outstanding; provided further, however, that, if the prohibition in this Section 4.17 remains applicable after the nine (9) month anniversary of the Closing Date as provided herein, the prohibition in this Section 4.17 shall no longer apply on the earlier of (a) the date on which no Closing Shares remain outstanding and (b) the date on which the 30-day average dollar trading volume of the Common Stock (as reported on as reported by Bloomberg L.P.) is higher than $20,000 per Trading Day.
You could be right, the market is looking for confirmation. That is essentially what I said. The market COULD be disappointed. Maybe something delayed the trial start. I could be disappointed. You gave an example of Novavax saying their trial was delayed but they also said the trial was to “begin in the coming weeks.” That sounds like Leo on timeframe specificity. Maybe in the case of IPIX the trial wasn’t delayed?
I don’t know. Lots coulds, mights, mays and ifs.
You are aware that there's an entire scientific community, commercial financial world (not millennials with $5k to 'invest'), regulatory agencies, foreign governments (and ours), all keeping an eye on progress within the space, right?
They don't care about BS PR innuendo. They care about concrete and verifiable events/results.
Leo's refusal to commit to dates/times without explanation for everything is an anomaly. It's shady and unprofessional and it doesn't do anything to build trust.
Some general examples of what people could be watching within the space:
-https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-therapeutics-tracker
-https://www.fdatracker.com/covid-19-clinical-trial-tracker/
-https://www.marketwatch.com/investing/pharmaceutical nothing here...
..or here: https://clinicaltrials.gov/ct2/results?cond=&term=Brilacidin+&cntry=&state=&city=&dist=&Search=Search
Concerns related to C19 plays:
https://observer.com/2020/03/coronavirus-covid19-stock-market-biotech-pharma-vaccine-drug/
“There are various biotechs claiming to be advancing a coronavirus vaccine that make similar claims with the medical crisis of the day,” Lichtenfeld told Observer. “When Ebola and Zika were making headlines, some of these companies suddenly had a vaccine development program for those conditions too. Those companies never produced a vaccine and won’t with coronavirus either.”
Meanwhile, Novavax’s COVID-19 vaccine candidate is also undergoing a Phase 1/2 trial in the U.S. and Australia. On Nov. 30, the company announced that it expects its pivotal Phase 3 clinical trial in the U.S. and Mexico to begin “in the coming weeks”. The timing of the trial has already been delayed twice.
B. Riley Financial analyst Mayank Mamtani pointed out that Novavax stock has been largely range-bound in 4Q as the delay of the Phase 3 clinical trial in the U.S. has sparked investor concern about execution risk.
I think people expecting a news release to say what Leo already said - the trial is scheduled to start next week (now last week) - are going to be disappointed. BWDIK?
...or how about... an actual trial instead of just PR's?
...or an explanation of why it's not happening?
First it was 4Q, then Jan, then 'next week', now it's almost mid-Feb and still nothing?
The MFO gave everyone a wake-up call today I think.
Only what, 40M more shares to go for them to further dilute the OS?
Did you expect a continued stock increase based on trial start news? The reality is take profits and don't have to worry about results. Nothing has changed except Fast Track Designation which they've received before... How about grant money!!!
That's actually poorly represented. Everyone is laughing at the company because it's a penny-stock.
This does nothing positive for visibility.
IPIX made it on WallStreetBets, uh oh!
https://www.reddit.com/r/wallstreetbets/comments/ldp88b/stonks/?utm_source=share&utm_medium=ios_app&utm_name=iossmf
...and yet, we still have no concrete details about.... anything?
Just vague windows of time with no explanation or verification.
I wonder why this is?
ps. "Enrolled" is defined as the signing of an informed consent to participate in the trial. The day the first person does that is the Study Start Date.
Israel + Pfizer article:
https://www.timesofisrael.com/high-israel-contagion-rates-blur-effect-of-pfizer-shot-on-virus-transmission/
Two jabs
Pfizer recommends administering its vaccine in two doses, three weeks apart.
Israel has enough stocks to follow these recommendations, meaning it does not have data on whether the protective effect from just one jab increases after 24 days in the absence of a second jab.
Maccabi has also released preliminary data on the second jab’s impact.
It showed that out of 248,000 people studied one week after receiving their second injection, only 66 mild coronavirus infections were registered.
While those figures point toward near-total protection, Maccabi has stressed this data has not been fully analyzed.
Tough to tell. What strains were present? I don't remember hearing aboit new ones in Israel.
Right... the whole cryptic-communication, obfuscation game-plan seems to fly in the face of convention with respect to attempting to instill confidence in investors and to get helpful info into the hands of an anxious public, in light of a raging pandemic taking place currently. Hoping this doesn't go like the B-OM disclosures were managed. SUCH a shit-show from a business-perspective.
More info would be helpful than less, currently... I feel.
I would welcome transparency for a change. This opportunity could be pivotal for the company. My fear is that Leo may not seize it and capitalize upon it as he otherwise could. I'd like to see an authorization (EUA at the least) following a successful trial, ASAP.
The initial trial registration must be done within 21 days of the enrollment of the first participant.
Updates/changes are different:
"Responsible Parties should update their records within 30 days of a change to any of the following:
Recruitment Status and Overall Recruitment Status data elements on ClinicalTrials.gov"
One of the Overall Recruitment Status data elements deals with Facility Location.
FWIW (and it may not be much) the first Version of the B-OM P2 trial (61 participants) was posted on 12/29/14. The first location was posted on 5/26/15. The last location was listed ("Recruiting") in June of 2017.
I don't think it's possible to anticipate when things are going to happen and/or when we'll find out about them.
https://clinicaltrials.gov/ct2/history/NCT02324335?A=20&B=21&C=Side-by-Side#StudyPageTop
https://clinicaltrials.gov/ct2/manage-recs/how-edit
They do, but I think there's a window of time for disclosure for trial details with CT.gov? 21 days or something, from events?
I'm pretty sure the trial site locations need to be provided as part of the clinicaltrials.gov registration.