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TIAB, has your hospital participated in any clinical trials for COVID therapeutics? If so, can you give an idea of what was done? If not, can you explain why?
Look forward to your comments.
That is a cavalier brushoff of ivermectin.
Ivermectin has been dosed nearly 4 billion times over the past 30 years. It’s moa and safety issues are well known. Ivermectin is taken orally which is a huge advantage. Ivermectin has shown in vitro antiviral activity against viruses, including HIV, influenza, Zika, and COVID-19. There are 47 clinical trials for ivermectin for COVID-19 listed on ClinicalTrials.gov, including 22 that are currently recruiting (3 in the US).
Ivermectin is well ahead of brilacidin as a therapeutic for COVID-19 even with it’s documented weaknesses. It’s very interesting to see the uptake of this drug since it is unsponsored. There are no high-profile politicians promoting its use or deep-pocketed bp buying their way into scientific consciousness or clinical trials. Instead, there has been consistent investigation and research to clarify the potential of ivermectin to treat COVID-19.
A couple recent YouTube videos might be worth watching:
Dr. John Campbell posted on Dec 12th, “Ivermectin and COVID”. I’ve been watching his YouTube channel since the early days of COVID and have found his commentary to be unbiased, conservative, and easily understood. His videos are somewhat slow paced.
Ivermectin and COVID 19
Ford Brewer, MD MPH posted a video today, January 2nd, “Ivermectin for COVID-19”. His vid covers much of the same material without the fancy British accent.
Ivermectin for COVID-19
The Front Line COVID-19 Critical Care Alliance (FLCCC) has developed a MATH+ hospital treatment protocol for COVID-19. Ivermectin is considered a core mediation. You can see their protocol here.
MATH+ hospital treatment protocol for COVID-19
Ivermectin has it’s flaws, but it’s also equally clear that many scientific institutions are working very hard right now to establish it’s therapeutic potential.
I wish good things for IPIX, but it's an insanely competitive field. There are 2,186 COVID-19 clinical trials currently recruiting patients. The sponsors of the trials are competing for the same pool of patients. Many have more robust scientific data and heaps more money to support their efforts and get the attention of hospital administrators and decision makers.
That doesn't change my opinion of whether or not the trial started. I want to see patients get dosed to see if brilacidin is a therapeutic option. Whether that happens in the US or elsewhere makes no difference to me.
I have my doubts as to whether it will work and, as I've written before, the Dec 9th financing arrangement will have a depressing effect on sp until we get a stellar pr from IPIX.
I agree with another poster's comment that results may not be known until 2nd quarter of 2021.
In my book, the trial start was achieved when the external obstacle was removed. Meaning, when the FDA granted approval to proceed. That was the piece IPIX had no control over.
Whether or not the trial proceeds is another matter. And then there's the itty bitty issue of whether it succeeds.
A chunk of selling today was tax loss selling. Today was the last day to sell and offset gains for 2020 tax bill. I'm interested to see how things go over the next 3-6 weeks while we await news on the clinical trial.
The Aspire deal and IPIX shareholders
In my post yesterday I showed that the Dec 9th purchaser could purchase shares at $0.123. If IPIX had instructed Aspire to purchase these exact same shares they would have paid $0.1676. That’s a difference of 36%. ((Need to take into account that IPIX granted Aspire 6,250,000 shares to consummate the $30 mil financing — call it 5%.)) So IPIX is financing themselves at a cost that is 30% higher than what it would have been had they stayed with Aspire. Does this make business sense to anyone?
Add to that the fact that in the Aspire deal IPIX is the one who decides when to trigger a purchase by Aspire. They can pick and choose the dates that work to their advantage. It’s the other way around in the Dec 9th deal.
Below is what I used to come up with the Aspire price.
The criteria for the pricing of an Aspire purchase:
Not sure you can extrapolate a final share count. In any case, my concern is not the total number of shares outstanding, but rather the way the new shares will enter the market and the overhang that will deter new investors (especially those who are more sophisticated). And keep in mind that this latest financing is not much money compared to what is needed to develop a drug, and IPIX will likely be looking for more money in the not too distant future.
You might find it interesting to look at what happened to the share price in 2018 when IPIX did a smaller round of financing with the same terms as the Dec 9th deal. I did a post about that a few weeks ago and here are the important bits (including the press releases that were issued by IPIX).
IPIX share price and the challenge ahead.
I may sound like a broken record, but a review of the math of the deal that IPIX entered into on Dec 9th is a graphic illustration of the amount of downward pressure that will be exerted on IPIX stock in the foreseeable future. The deal is as follows:
Dec 9 — 3,053 shares of preferred stock
Dec 9 + 60 trading days — 2,036 shares of preferred stock
Warrants to purchase another 10,019 shares of preferred stock split evenly between Series 1 warrants that expire in 18 months and Series 2 warrants that expire in 24 months.
The conversion of preferred stock to common is as follows:
1. Each share of preferred stock has an initial stated value of $1,080 (the purchaser paid $982.50 so they get 10% right off the bat).
2. Each share of preferred stock gets converted according to the following formula (the math example I’m presenting assumes “(ii)” as the conversion mechanism and the acronym for volume weighted average price is VWAP):
Yes. The company was CTIX when I bought in 2010.
That's pretty good! Congratulations! I bought some at $0.06 on Nov 27, 2019.
Do you remember why you bought when you did? I don't remember. Those were dark days compared to today.
I bought my first shares in 2010 for $0.17.
Merry Christmas! Best wishes to all for the coming year!
I see it as a requirement to do the deal, not an artifact of the deal. The lawyer did not come up with the number independently. The "purchaser" set the figure of 150,000,000 and the purchaser wanted the legal opinion. And the figure itself is not simply a guess. There is something behind it and one discounts these numbers as academic at their peril.
Likewise, I don't think the figure of a minimum share price of $0.07 as a condition of the second closing is academic. It may not be exact, but the direction the purchaser is willing to see the share price go cannot be mistaken.
If the purchaser expected the share price to increase they would have set a higher minimum for the second closing. If the purchaser expected the share price to increase there would have been no reason to get an opinion specifying that IPIX had 150,000,000 shares available to be issued upon conversion of the preferred shares.
A potential investor in IPIX looks at the science/timeline of clinical trials, the competition, the cash position, and considers the amount of dilution on tap. It's not a pretty picture imo.
Remember that a condition of the most recent financing was that IPIX had 150,000,000 shares available to be issued upon conversion of the preferred shares. That information is in one of the legal opinions that were included as part of the 8K (opinion). The opinion was not an academic exercise, but rather the anticipation of a real event.
I think this is what they're referring to:
Thank you for the insight.
You say, "The "right" news could push to $1 or more easily."
Is your software able to model/chart the stock price for the release of common shares when the preferred Series B-2 are converted? For example, can you play out the scenario where 15,000,000 new shares are sold into the market on the "right" news? I'm not trying to be wise ass.
I was thinking of a dipping sauce. Gluten free will sell it!
I think it's humorous. Maybe someone at IPIX has already contacted the National Mango Board about a combination therapy.
Mango gets a clinical trial before brilacidin.
There are about 400 drugs/compounds in clinical trials for COVID-19 (see Current worldwide clinical trials on COVID-19). Among the more unique items in clinical trial include:
Coconut oil, 1
Mango, 1
Licorice, 1
Onion, 1
Morphine, 1
Carbon monoxide, 1
Note: The number "1" means they're in 1 clinical trial. Could be anywhere in the world.
Pre-paying for vaccines in Operation WARP Speed and the $600 weekly bonus to the unemployed in one of the early stimulus packages were both brilliant ideas, imo.
I'm holding at this point in the hopes for a pop on a good PR and will sell a portion of my position.
I cannot put on blinders and ignore the amount of dilution waiting in the wings. I also cannot put on blinders as to the validity of the RBL testing. Imo the results of the RBL testing are not clinically reproducible. The testing was done at a concentration of 10µM which equates to an IV dose of 0.78 mg/kg. As we saw from the ABSSSI P-2b presentation in 2015, a single dose of 0.80 mg/kg resulted in hypertension >160 mmHg in 17% of the subjects. Given that the clinical trial is supposed to treat hospitalized patients already in respiratory distress (where elevated blood pressure is a problem) this is a big red flag imo. I expect they will use a significantly lower dose and that will reduce efficacy.
But given the market cap <$60m a well-written PR could pop the stock.
I invested in this company because of kevetrin.
You can figure it out if you compare the chemical structure of brilacidin to the 2 candidates they identified:
Thanks for pointing this out.
The point I was trying to make about Aspire is that they couldn't time the market the way this new purchaser can. Although Aspire had shares at their disposal they had no way of knowing when IPIX would issue a purchase request. IPIX controlled the timing of that request. That's a big difference imo.
So what happened in 2018? I took a look at the period from when the deal was announced to the end of the year 2018. I also looked at the PRs that IPIX issued during the same time period (list is below).
On the day the deal was announced, IPIX opened at $0.24. At the end of 2018 IPIX closed at $0.10 (they opened that day at $0.08). The PRs that IPIX issued during the time period suggested that positive things were happening on multiple fronts. Also, IPIX was a more robust organization with core staffing in place in 2018.
If you think the timeframe is too short, the share price closed on October 7, 2019 (1 year out) at $0.11. The decline in share price was most likely the result of dilution imo.
October 09, 2018
INNOVATION PHARMACEUTICALS SECURES UP TO $10 MILLION IN ADDITIONAL FINANCING TO ADVANCE CLINICAL PIPELINE
October 12, 2018
INNOVATION PHARMACEUTICALS BRILACIDIN AS A NOVEL INHIBITOR OF PHOSPHODIESTERASE 4 (PDE4) SUPPORTS ITS POTENTIAL TO TREAT AUTOIMMUNE AND INFLAMMATORY DISEASES
October 22, 2018
INNOVATION PHARMACEUTICALS PROVIDES UPDATE ON KEVETRIN PROGRAM; BRIDGING TOXICOLOGY EFFORTS AIMED AT DEVELOPING AN ORAL P53 ANTI-CANCER DRUG CANDIDATE
October 24, 2018
INNOVATION PHARMACEUTICALS GRANTED END-OF-PHASE 2 MEETING
November 01, 2018
INNOVATION PHARMACEUTICALS EXPANDS BRILACIDIN PATENT PORTFOLIO
November 08, 2018
INNOVATION PHARMACEUTICALS PROVIDES CORPORATE UPDATE HIGHLIGHTING BUSINESS DEVELOPMENT AND CLINICAL PIPELINE PRIORITIES
November 13, 2018
INNOVATION PHARMACEUTICALS PRESENTING BRILACIDIN FOR INFLAMMATORY BOWEL DISEASE AT “IBD INNOVATE 2018” CONFERENCE HOSTED BY THE CROHN’S & COLITIS FOUNDATION
December 17, 2018
INNOVATION PHARMACEUTICALS COMPLETES END-OF-PHASE 2 MEETING WITH FDA; BRILACIDIN ORAL RINSE TO ADVANCE INTO PHASE 3 CLINICAL TRIALS FOR PREVENTION OF SEVERE ORAL MUCOSITIS
As an IPIX shareholder, I agree that it’s good for IPIX to get financing. It’s also good to understand the quality of the financing they’re entering into. There are differences. Companies with poor prospects that need constant financing exhaust traditional methods and end up burdening their shareholders with financing that dilutes their investments unnecessarily.
While I was no great fan of the Aspire deal, in my opinion this latest financing is predatory. You need look no further than the fact that the purchaser has stated that they can and will short the stock (see (hh) Acknowledgment Regarding Purchaser’s Trading Activity), they can and will trade on the basis of material, non-public information (see 4.9 Non-Public Information), and there is no lock-up period (see 4.1 Underlying Shares.).
This is not an “investor” who is interested in seeing the company succeed. The purchaser will set about maximizing their profit. Their profit will be maximized by driving down the share price to purchase and selling heavily on any spikes. This is dilution at it's worst.
Another poster suggested that this deal was proof that IPIX had a strong hand (material, non-public information sealed the deal). That’s not the way the deal reads. The purchaser gets 10% right off the top (they pay $982.50 for a preferred share that immediately becomes worth $1,080). The purchaser then buys shares at 85% of the lowest volume weighted average price of IPIX’s common stock on a trading day during the ten trading days prior to and ending on, and including, the conversion date. That’s a sweet deal!
IPIX had some control of the rate at which Aspire purchased the shares and, in turn, fed them to the market. That is not present with this latest purchaser. They have the control and they can manipulate the market down to purchase shares at rock bottom prices and sell at the first opportunity.
I hope IPIX has big news. It has to be big because there will likely be many millions of new shares sold into the market.
Here’s another tidbit from the deal: A usury clause.
What's also troubling about this latest financing is that the purchaser is able to short the stock and receive material non-public information from IPIX. The Aspire deal specified that they COULD NOT short the stock.
Shorting stock:
I agree that there is no "loophole" and agree with your estimate of when the Aspire Agreement becomes available.
As to the volume of the package -- I do not have the patience to work through the details to figure this out. Suffice to say that I have concluded that there will be a large, active, and motivated SELLER at every turn. That does not bode well for a sustained increase in share price.
I did look at the reference in the last paragraph and that prompted my comment about a loophole and even if IPIX could find one they wouldn't pursue it for fear of the penalties outlined.
Do I misunderstand?
The agreement anticipates the possibility that the authorized unissued shares will be less than the required minimum:
This goes back to 2016. It's not another patent. It's a continuation of application no. 15/042,923, filed on Feb 12. 2016.
There's a section called "Preparation of Brilacidin (PMX-30063)" that appears to be the recipe.
There are >50 clinical trials ongoing for Ivermectin as a treatment for COVID. It is being investigated aggressively.
I found (but didn't read) the following article from 2011. In this article you can see the many uses of Ivermectin in human populations.
Ivermectin, ‘Wonder drug’ from Japan: the human use perspective
My personal familiarity with Ivermectin dates back >30 years and that was as a dewormer in livestock.
Here's another nugget: There's a clause in "Section 10. Redemption Upon Triggering Events" of the CERTIFICATE OF DESIGNATION where the VWAP discount is increased to 70% from 85%.
The triggering events seem unlikely, but not impossible.
Yes. IPIX is anticipating that the preferred shares convert into 150 million Class A common shares.
Check out loanranger's earlier post about the math of the conversion.
IPIX has 150 million shares issuable for this financing. From OPINION OF GARY R. HENRIE, ESQ. as part of filing:
Very good summary of the deal. You asked about math, and I see one thing that needs fixing:
That's interesting. What trading platform are you using? E-Trade seemed willing to take my "Market" order. I didn't place one because I don't want more shares.
Along those lines, a couple weeks ago a poster mentioned their "stop loss will get triggered" on their IPIX position. I questioned them on their trading platform and they said they were using Fidelity and TD Ameritrade. E-Trade does not allow Trailing Stops on ". . . bulletin board, pink sheet and other specific securities . . ."
Weird. I use limit orders 99% of the time.
It’s true that blood pressure increases to levels > 160 mmHg were AEs in the ABSSSI Phase 2b testing. A single dose of 0.6 mg/kg caused hypertension in 3.8% of the subjects. A single dose of 0.8 mg/kg caused hypertension in 17% of the subjects. A 3-day regimen of 0.6 mg/kg for D1 and 0.3 mg/kg for D2 & D3 caused hypertension in 26%.
I'm more interested in what dose will be used for the upcoming clinical trial for COVID.
The poster “wsbc” brought the following sentence from the paper posted by the RBL to my attention:
IPIX news out:Innovation Pharmaceuticals COVID-19 Clinical Trial to Support Additional Development of Brilacidin as a “Pan-Coronavirus” Therapeutic
November 30, 2020
Innovation Pharmaceuticals COVID-19 Clinical Trial to Support Additional Development of Brilacidin as a “Pan-Coronavirus” Therapeutic
· Company advancing Brilacidin as a next-generation broad-spectrum antiviral for the treatment of common colds and deadly coronavirus infections
WAKEFIELD, MA – November 30, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces additional independent preliminary laboratory research suggests Brilacidin, the Company’s flagship defensin mimetic, has the potential to treat other endemic human coronaviruses (H-CoVs), such as those causing common colds, and not just SARS-CoV-2, the novel coronavirus responsible for the ongoing global COVID-19 pandemic. Research shows Brilacidin exerted potent in vitro inhibition of multiple strains of H-CoVs. On completion of testing, the H-CoV findings are expected to be submitted for peer-review publication. The Company is evaluating these data alongside previously obtained SARS-CoV-2 data, strategizing with its scientific advisors and consultants, to develop Brilacidin as a “pan-coronavirus” therapeutic.
In related news, requisite documentation has been filed with the appropriate regulatory agencies, including an Investigational New Drug application (IND) with the FDA, for conduct of a multinational Phase 2 clinical trial of Brilacidin in patients hospitalized with COVID-19.
Innovation Pharmaceuticals believes Brilacidin is a clearly differentiated leading antiviral drug candidate backstopped by a growing library of laboratory data documenting Brilacidin’s potent ability to inhibit coronaviruses, primarily by disrupting viral integrity and blocking viral entry. The Company is planning to conduct additional in vitro and in vivo Brilacidin studies on multiple coronaviruses, to further inform the drug’s anti-coronavirus properties and prepare for potential future clinical testing.
“Given the alarming recent global spike in COVID-19 cases, coupled with a long-term perspective around the possibility of future pandemics, the appetite for novel anti-coronavirus therapeutics remains strong, as evidenced by Merck paying $425 million in cash last week to acquire OncoImmune to bolster its COVID-19 pipeline,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Early data on vaccines are an encouraging development in combatting the virus. But vaccines have their own challenges—notably, reticence among the public to get vaccinated, combined with delivery obstacles and potential resistance developing due to mutations. Vaccines offer only a partial solution. Major pharma understands this and it is why they are making significant investments in promising COVID-19 therapeutics. The clinical trial of Brilacidin for COVID-19 will be instrumental in taking the first step to develop Brilacidin as a ‘pan-coronavirus’ drug, benefiting patients with illnesses ranging from variants of the common cold to the most serious coronavirus infections.”
Brilacidin and COVID-19
Brilacidin is one of the few drugs targeting COVID-19 that has been tested in human trials (a total of 8) for other clinical indications, providing established safety and efficacy data on over 460 subjects, thereby potentially enabling it to rapidly help address the novel coronavirus crisis. Laboratory testing at independent laboratories supports Brilacidin’s antiviral ability to safely and potently inhibit SARS-CoV-2. In a human lung cell line, Brilacidin achieved a Selectivity Index of 426. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. Brilacidin anti-viral research to date has been limited to laboratory-based experiments. Additional pre-clinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1ß, TNF-a and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients. Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. Collectively, these data support Brilacidin as a unique 3 in 1 combination—antiviral, immuno/anti-inflammatory, and antimicrobial—COVID-19 therapeutic candidate. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded on bioRxiv.org at the link below.
· Brilacidin, a COVID-19 Drug Candidate, Exhibits Potent In Vitro Antiviral Activity Against SARS-CoV-2
https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1.full
Global COVID-19 Cases and Mortality
An online tool tracking COVID-19 cases and mortality, both in the U.S. and globally, can be found on the Company’s website ( http://www.ipharminc.com ), and at the following link: https://ipixcovid19tracker.com/
The AEs in the Phase 2B trail in ABSSSI need to be considered as well. There were significant AEs at all dosing levels, including the lower dose 3-day regimen (0.6 mg/kg D1; 0.3 mg/kg D2 & D3). See slide 18 from IPIX’s 2015 presentation slide deck.
25th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID 2015): “A Randomized, Double-Blind Study Comparing Single-Dose and Short-Course Brilacidin...
What dose will be effective for COVID patients while minimizing AEs? The RBL testing doesn't provide a clear answer.
The lowest concentration tested by the RBL was 10µM. A 10µM concentration is equivalent to a one-time dose of 0.78 mg/kg [[The Discussion section of the RBL paper referenced the clinically-achievable pharmacokinetics from the ABSSSI Phase 2b study and included the following, “median Cmax in plasma was 7.67µM brilacidin (free-base) from a single IV dose of 0.6 mg/kg.” I used simple math to calculate mg/kg for 10µM.]]
In the ABSSSI study, 81% of the participants who received a single-dose of 0.8 mg/kg experienced AEs, and 17% experienced hypertension >160 mmHg. The lower dose given multiple times had more AEs -- 92% of the participants on the 3-day regimen (dosing of 0.6 mg/kg D1; 0.3 mg/kg D2 & D3) had AEs, and >26% experienced hypertension >160 mmHg.
I'm curious to see what dose IPIX and the FDA determine to be safe and effective. Given the AEs experienced by the ABSSSI participants, I would be surprised if the FDA allowed a clinical trial to go forward that was designed to achieve the 10µM concentration used in the RBL testing.
There's lots of competition for biggest biotech scammer. For example, CTI Bio (CTIC) has over $2.25 billion in accumulated deficit. IPIX is a pipsqueak at $102 million.
I think I follow what you're saying in theory, but don't see how it would work in practice.
This is how I interpret the theory: The mm has a large sell order. In order to not spook the market they do not list it as a sell. Instead, they place a visible large buy order. This gives investors the appearance of interest and those investors place additional buy orders that the mm fills with the large sell order. Do I have it right?
How does the mm keep their sell hidden and how do they beat the market to fill the bid?