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I don't see any upside to the 60 day phone call.
The best you can hope for is that it confirms what they knew at Day 29: No lingering side effects from brilacidin.
The only data it can add is NEGATIVE . . . that the subjects who received brilacidin are experiencing lingering side effects.
We already know what remdesivir does since it's been administered to hundreds of thousands if not millions of subjects.
Seems pretty straightforward to me.
Given the revenue potential for 2021 that you cite, would you expect that IPIX management would be pressing the FDA to relax the protocol to collect the final piece of data at day 60?
The DMC will have 60-day data on at least 84 of the subjects and all of the other “Primary”, “Secondary”, and “Other” endpoints will be met at day 29. To sit idle while the clock runs for an extra 30 days (representing >20% of the available revenue-generating time in 2021) is negligent imo.
The 60 day telephone call was put in during trial development when IPIX expected the trial would fill quickly (perhaps a week or two). Now that the trial has taken 4 months to recruit, the 60 day telephone call looks misguided and deserves to be pursued with the FDA by IPIX management.
Here’s my post from this weekend about this subject.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164230458
BTW -- We're in real trouble if the 60 day telephone call is really necessary since that means that IPIX is aware of lingering effects of brilacidin. We have been led to believe that any TRAEs of brilacidin were transient and resolved shortly after treatment. This 60-day call is 55 days after treatment ends.
“What protocol do you suggest or expect them to break???”
I think a case can be made to unblind the data when subject 120 completes their study visit on Day 29 (earlier if the subject dies). I don’t think waiting until Day 60 for the follow-up phone call is required.
Follow-up period (Day 4-6 through Day 60): Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 15 and 29. A follow-up visit at Day 60(±10), by telephone call, is also included to confirm patient status.
Actually Longpicker made my point.
The in vitro study did something in the test tube that cannot be done in the human body. They preincubated the virus with brilacidin before introducing the virus to the Calu-3 cells. By doing that, they increased the inhbition of SARS-CoV-2 in Calu-3 Cells by 243%.
They say it right here (emphasis added):
The inhibitory effect of brilacidin in the Calu-3 cell line was first confirmed by pretreatment (for 2 h) and postinfection treatment (for 24 h) of cells with brilacidin, which demonstrated a dose-dependent decrease of viral load, with the higher concentration of brilacidin providing 61% inhibition of infectious viral titer (Figure 3A). However, when the experiment was modified to include a brilacidin-treated inoculum—with preincubation of the virus with brilacidin for 1 h prior to infection, and with infection carried out in the presence of the compound—the extent of inhibition dramatically increased, resulting in 95% and 97% reduction of infectious viral titer at the 10 and 20 µM concentration of the compound, respectively (Figure 3B).
Do you not see an issue with preincubation? There was data without preincubation and then they started preincubating the virus with brilacidin for 1 hour.
Preincubation makes a big difference. The 10µM concentration went from 39% to 95% -- an improvement of 243%.
Preincubation is not possible in the clinical trial.
Not a concern?
I appreciate your post and have appreciated many of your posts in the past. Full disclosure, I don’t often read the articles in your links.
I’m certain you’ve read the viruses paper and have looked at Figures 5B and 5C on page 9. I assume you read those figures the same way I did: Remdesivir, when tested alone, reduced viral titer by 99% and brilacidin, when tested alone, reduced viral titer by 90% at the highest concentrations tested. Remdesivir and brilacidin, when tested in combination, reduced viral titer by >99% at the highest concentrations tested.
You point out that the in vitro promise shown by remdesivir didn’t translate to the clinical setting and you presented numerous reasons why brilacidin should do better.
I’m curious to get your opinion on the importance of preincubating the virus with brilacidin during the in vitro testing. Here’s some of my thinking on it and what impact it might have on the potential for brilacidin in the clinical trial.
In section 3.3, where brilacidin is tested in Calu-3 cells, they first test brilacidin without preincubation. These are the result:
10µM = 39% reduction
20µM = 61% reduction
They then did the following:
However, when the experiment was modified to include a brilacidin-treated inoculum—with preincubation of the virus with brilacidin for 1 h prior to infection, and with infection carried out in the presence of the compound—the extent of inhibition dramatically increased, resulting in 95% and 97% reduction of infectious viral titer at the 10 and 20 µM concentration of the compound, respectively (Figure 3B).
Quantification of the inhibitory response—when the virus was directly preincubated with brilacidin prior to infection; cells were treated prior to infection; brilacidin was present during infection; and infected cells were maintained in the presence of brilacidin postinfection . . . .
Go to page 9 of the GMU paper, Figure 5B and Figure 5C. It shows the results of testing for brilacidin and remdesivir separately and in combination. Identical conditions. There you will see that remdesivir reduced the viral titer by 99% by itself while brilacidin reduced it by 90%.
IPIX issued a press release about this testing but only mentioned the combination of brilacidin and remdesivir achieving nearly 100%. It's only when reading the GMU data that you see remdesivir was 99% by itself.
I grant that brilacidin has a different MOA, but the testing done by GMU shows that when they tested the two drugs under identical conditions remdesivir was a more potent antiviral than brilacidin.
Here's the GMU paper published in viruses: Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture
Here's the IPIX press release: Laboratory Testing of Brilacidin for COVID-19 in Combination with Remdesivir Reduces Viral Load by Nearly 100 Percent
“Thus far I’ve only seen indication and data that it works, . . .”
Here’s a summary of my opinion on the GMU testing and clinical trial of brilacidin. I think I’ve posted all of this in earlier posts. Suffice to say I am not a fan of brilacidin. I got into CTIX/IPIX in 2010 for kevetrin and have hung around for the fun ever since! I am not a doctor.
1. Strong GMU in vitro data was based on virus being preincubated with brilacidin. Not possible in trial. The trial patients have been overrun by the virus and their immune system is destroying their tissues to fight the virus.
2. The GMU in vitro data compared brilacidin to remdesivir and showed that remdesivir was more effective at inhibiting the virus. Remdesivir inhibited 99% vs brilacidin 90%.
3. To achieve the concentrations of the GMU in vitro data would require dosing at much higher levels than what was used in 3-day ABSSSI P2 dosing regime (0.6 mg/kg, 0.3 mg/kg, 0.3 mg/kg). That 3-day dosing regime in ABSSSI P2 trial had 92% TRAE including 26% with hypertension. Patients in ABSSSI trial were otherwise healthy whereas the hospitalized COVID patients are very ill and weak.
4. Fact that the dose was increased from 3 to 5 days in clinical trial suggests a very low dose is being used. I don’t think they would authorize the dosing increase unless the TRAE were much less than what was seen in the ABSSSI P2. So the dose is quite low and without preincubation has modest antiviral effects based upon the in vitro data presented by GMU. By modest I mean a concentration of 2.5 µM of brilacidin (an 0.2 mg/kg dose) might kill 8% of the virus over a 24 hour period. The virus replicates every 9 hours. Keep in mind that the half-life of brilacidin is about 16 hours which means you need to give a higher initial dose to achieve a specific concentration (the trial indicated people would be dosed 1x day).
Brilacidin does have a unique MOA and other good things about it, but my conclusion is that it’s antiviral properties are not going to be well illuminated in the trial of hospitalized COVID patients. Brilacidin could have other antibacterial and anti-inflammatory properties, but both of those have existing drugs that are more targeted to the indication — brilacidin is a shotgun when what you need is a rifle.
I own IPIX and am optimistic that IPIX stock will appreciate. The valuation of the company is low, the amount of money sloshing around is large, COVID is still present, and the number of uninformed speculators is vast. It won’t be pretty. IPIX should be able to issue some strong PRs that get interest. One wildcard is whether they will do another round of financing. That would hurt.
The negative reaction in the market is likely due to this sentence from yesterday’s PR: “Final data collection for the last patient enrolled in the study is expected to occur in early August (Study Day 60), which will then be followed by the process of unblinding study data and the reporting of topline study results.”
The "August (Study Day 60)" is a head scratcher when you look at the "Primary", "Secondary", and "Other" outcomes from the trial A Study to Evaluate the Efficacy and Safety of Brilacidin in Hospitalized Participants With COVID-19.
All but one end on or before day 29. Only #10 of the "Secondary" outcomes has a later date.
Primary Outcome Measures:
1. Time to sustained recovery through Day 29 [ Time Frame: Day 1 through Day 29 ]
Secondary Outcome Measures:
1. Proportion of subjects achieving recovery status scores at Day 29 [ Time Frame: Day 29 ]
2. Proportion of subjects that die or develop respiratory failure by Day 29 [ Time Frame: Day 1 through Day 29 ]
3. Subject Clinical status [ Time Frame: Day 1 through Day 29 ]
4. Proportion of subjects achieving at least one category improvement in clinical status [ Time Frame: Day 8, Day 15, Day 29]
5. Proportion of subjects achieving at least two category improvement in clinical status [ Time Frame: Day 8, Day 15, Day 29 ]
6. Time to at least one category improvement in clinical status [ Time Frame: Day 1 through Day 29 ]
7. Time to at least two category improvement in clinical status [ Time Frame: Day 1 through Day 29 ]
8. Time to a National Early Warning Score 2 (NEWS2) of </= 2 and maintained for 24 hours [ Time Frame: Day 1 through Day 29 ]
9. Change from baseline in National Early Warning Score 2 (NEWS2) [ Time Frame: Day 1 through Day 29 ]
10. Incidence of treatment-emergent adverse events [ Time Frame: Day 1 through Day 60 ]
11. Incidence of treatment-emergent graded laboratory abnormalities [ Time Frame: Day 1 through Day 29 ]
Other Outcome Measures
There are 11 of them of which 9 end on day 29, 1 ends on day 15, and end on day 4.
You can download a PDF of Fauci's emails here: Fauci Emails.
I got the link from this article: Anthony Fauci’s Emails Reveal The Pressure That Fell On One Man.
I did a search for "brilacidin" and "innovation" and came up empty. There are some redactions. Let us know if you find something interesting.
Polymedix did a Phase 1 exposure-escalation study with brilacidin (PMX-30063) that showed that patients who received high doses, or prolonged exposure, and experienced paraesthesia resolved within 7 days after discontinuation. So the "numbness and tingling" would probably not be part of the 60 day follow-up.
Dr. Korczak also presented, in oral and poster format, results from PolyMedix’s Phase 1 exposure-escalation study in twenty subjects where a high dose of PMX-30063 was administered for up to fourteen days. Following subjective and objective neurological assessments conducted by the study investigator and a Board-certified neurologist, the most frequently reported side-effect was sensory symptoms of tingling and numbness. All symptoms completely resolved on their own within seven days after discontinuation of administration. These results support the principle that temporary affects on ion channel function in peripheral nerves, and not neurotoxicity, are likely associated with some patients experiencing paraesthesia when receiving higher doses or prolonged administration of PMX-30063.
Would it surprise you to learn that in 2020 the FDA granted Fast Track Designation to 67% of the applicants? (Cumulative FY CDER Fast Track Designation Requests) I wonder why more drug companies do not apply for Fast Track Designation since it seems pretty easy to get. 2 out of 3 ain't bad.
When the PR was issued about IPIX being approved for Fast Track Designation I commented that my hope was that it would carry weight with the administrators at the hospitals they were trying to get to sign-on for the clinical trial. I have to assume my hopes were misplaced since IPIX is currently recruiting at only 2 US-based facilities. 2 out of 14 ain't good.
Can you provide the link to the article that was published in the journal Cell Culture that's referenced in the Precision Vaccinations article?
On February 9, 2021, the journal Cell Culture published a paper that concluded Brilacidin was shown to exert potent inhibitory effects on SARS-CoV-2 in cell culture by decreasing viral load in different cell types, including ACE2 positive human lung cells, and, importantly, in both the Washington and Italian strains of the coronavirus. Testing of Brilacidin against additional SARS-CoV-2 strains is planned, concluded this paper.
I got a chuckle out of hearing Leo moved you to spam and actually took the time to tell you he did it. Reminds me of a CFO at a company I used to work at who would spend hours reformatting floppy disks rather than spending $0.40 to buy a new one.
On the bright side, it suggests he reads his emails.
This is exactly the kind of misleading PR I was referring to. Why? We now know that IPIX paid for the research.
I'm not criticizing the research, just the way IPIX portrayed it in the PRs.
For those interested in a fuller understanding of the Innovation Pharmaceuticals Inc. vs. Cummings Properties, LLC lawsuit, you can go here: Massachusetts courts website
Once you get by the “I’m Not a Robot” screen, select “The Superior Court”, then “Essex County”, then click on the tab “Case Number”, input 2077CV00101, and you are given links where you can review all of the documents.
The letters between the lawyers are especially interesting to me. Those are included as part of the “Defendant Cummings Properties, LLC: Answer with a counterclaim”.
I was pleased to see that IPIX contested the lease renewal in April 2018. That said, it was management incompetence to not have sent the proper written notice. Likewise, it was incompetence to not have read paragraph 2 of the 2013 lease renewal to appreciate the terms they put their signature to.
Pre-trial conference is scheduled for March 25, 2022 which could make loanranger’s prediction that the current lease will expire before the case is resolved prescient.
I expect that any company interested in doing business with IPIX will review this case.
How did you connect a conference to my response to a poster writing that brilacidin research was "free"?
In any case, to get a better idea of the degree to which IPIX's was involved in the paper Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture that appeared in the journal viruses, you can look at the “Author Contributions” section. In that section, “W.K.W.” stands for Warren K. Weston, an IPIX consultant and “J.A.H.” stands for Jane A. Harness, an IPIX employee.
Conceptualization, A.B., A.N., T.L.C., W.K.W., and J.A.H.; Methodology, A.B., W.K.W., J.A.H.; A.B., K.R., N.B., F.A., and T.L.C. conducted experiments; Visualization, Formal analysis, Data curation, A.B., A.N., W.K.W., T.L.C., and J.A.H.; Writing—original draft preparation, A.B., A.N., W.K.W., and J.A.H.; Writing—review and editing, A.B., A.N., W.K.W., and J.A.H.; Project administration, A.N., W.K.W., and J.A.H.; Funding acquisition, A.N., W.K.W., and J.A.H. All authors have read and agreed to the published version of the manuscript.
An IPIX employee or consultant is credited with the following:
Conceptualization
Methodology
Visualization, Formal analysis, Data curation
Writing -- original draft preparation
Writing -- review and editing
Project administration
Funding acquisition
The only category IPIX did not participate in was "conducting experiments".
It's important to note that I don't dispute the results. I don't think IPIX influenced events other than putting out misleading PRs that gave the impression that the testing was being done in a black box. I think many readers of this board believed that brilacidin had been selected for testing and that IPIX had to wait to get the results (remember those posts about IPIX will only know when the RBL decided to give them info?).
It's also important to recognize that this information was not disclosed in the preprint. It's possible there were readers of this board and others interested in IPIX who read the preprint and assumed the peer-reviewed version was the same.
Not sure what you mean by “free” research. Were you making a joke? IPIX paid for the research at GMU. Here’s the “Funding” section from the paper Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture that appeared in the journal viruses:
Funding
George Mason University, with identified lead researcher Aarthi Narayanan, received financial support from Innovation Pharmaceuticals Inc. to conduct research on brilacidin’s antiviral properties
Do you have a link to the Innovation Pharmaceuticals case? Cummings Properties, LLC is certainly no stranger to litigation and a May 28, 2020 appellate court decision concerns an automatically renewed lease that is similar to IPIX’s situation except in this case Cummings was the plaintiff (CUMMINGS PROPERTIES, LLC v. FRANCOIS & ASSOCIATES, LLC)
The original bench trial awarded possession to Cummings but not the liquidation damages they were seeking ("the net present value of the entire balance of rent due herein as of the date of LESSOR's notice, using the published prime rate then in effect"). The appellate court vacated that decision and returned the case to the trial court for an assessment of damages hearing.
Here’s a bit of the decision that makes it clear that automatically renewing leases are enforceable:
By application of the lease terms, in 2013, the lease extended automatically to July 14, 2018. In order for it not to have extended automatically for a successive five-year term to July, 2023, either Cummings or Francois was required to provide written notice to the other between July 14, 2017 and January 14, 2018. Neither party provided written notice during the requisite time period to the other. On April 18, 2018, Francois sent an e-mail that it would not be renewing the lease at the premises. Cummings replied the following day that the lease had already extended automatically because no written notice had been provided to the contrary. The trial judge's amended findings of fact (entered after Cummings filed a postjudgment motion pursuant to Mass. R. Civ. P. 59) included a finding that Francois's "April 2018 notice to [Cummings] was untimely by at least three months."
Francois paid rent through July, 2018 then returned the keys to the premises to Cummings that same month. According to the summary process complaint, Francois failed to pay rent for August and September, 2018. [Note 1] The tenant's consequences for a breach of the lease included rent acceleration through the end of the lease and collection of that amount as liquidated damages discounted to the net present value using the published prime rate then in effect, which Cummings calculated to be $44,220.08. [Note 2] Francois failed to cure the default, see note 1, supra, and Cummings filed the instant summary process action to recover possession and liquidated damages as called for in the lease.
Analysis. The breach. The tenant has the burden to prove that it fulfilled the termination option requirements in a lease. Patriot Power, LLC v. New Rounder, LLC, 91 Mass. App. Ct. 175 (2017). This is particularly true "where the condition for avoiding the contractual obligation actually requires an affirmative act by the party seeking to end the obligation." Id. at 179. Strict compliance with the terms of the lease having to do with notice is of particular importance where the parties agree that "time is of the essence." Such a clause "means that contractual deadlines will be strictly enforced." Owen v. Kessler, 56 Mass. App. Ct. 466, 467 (2002). "Under Massachusetts law, parties will be held to the deadlines they have imposed upon themselves when they agree in writing that time is to be of the essence." Id. at 469.
Are you basing your comment on your knowledge of commercial real estate lease agreements in Massachusetts? From what I've read, auto renewal (Evergreen) contracts are enforceable.
Here's "Lease Commitments" section from the 10-Q dated 9/30/18 (note, I highlighted the "automatically renewed" wording):
Lease Commitments
Operating Leases – Rental Property
On September 30, 2018, the Company’s lease agreement with Cummings Properties automatically renewed. The lease is for a term of five years ending on September 30, 2023, and requires monthly payments of approximately $19,000.
As of September 30, 2018, future minimum lease payments to Cummings Properties required under the non-cancelable operating lease are as follows (rounded to nearest thousand):
Year ending June 30,
2019 -- $228,000
2020 -- $228,000
2021 -- $228,000
2022 -- $228,000
2023 -- $228,000
$ 1,140,000
Rent expense, net of lease income, under this operating lease agreement was approximately $52,000 and $52,000 for the three months ended September 30, 2018 and 2017, respectively.
Our current Company headquarters are located at 100 Cummings Center, Suite 151-B, Beverly, MA 01915. The Company’s lease agreement automatically renewed with Cummings Properties on October 1, 2018. The lease is for a term of five years ending on September 30, 2023, and requires monthly payments of approximately $19,000. We are currently looking to sublease this property.
On January 22, 2020, the Company filed a complaint against Cummings Properties, LLC in the Superior Court of the Commonwealth of Massachusetts (C.A. No. 20-77CV00101), seeking, among other things, declaratory relief that the lease for the Company’s prior principal executive offices did not automatically extend for an additional five years from September 2018, return of the Company’s security deposit, and damages. This action is in the preliminary stages and the Company is currently unable to determine the probability of the outcome or reasonably estimate the loss or gain, if any.
Where are you getting 30 days from? Did you look at the site?
Trial posted: March 3, 2021
Updates:
March 5
March 17
April 14
April 19
Look for yourself.
Here's the Alfasigma milestone bit you asked about:
(i) Development Milestones
For the UP/UPS Indication:
(1) US$ 1 million, upon Commencement of the First Phase III Clinical Trial; and
(2) US$ 1 million, upon the first filing of the Marketing Approval application to the US Regulatory Authority (“FDA”) or the EU Regulatory Authority (“EMA”), as applicable, without any duplication;
(ii) Regulatory Milestones
For the UP/UPS Indication:
(1) US$ 3 million, upon obtainment of the Marketing Approval from FDA; and
(2) US$ 1 million, upon obtainment of the Marketing Approval from EMA.
(iii) Sales Milestones
Milestone upon achievement of the following aggregate Net Sales
Payment
First achievement of US$ 100 million, US$ 3 million
First achievement of US$ 200 million, US$ 6 million
First achievement of US$ 300 million, US$ 9 million
ALFASIGMA shall notify IPI in writing of the occurrence of any applicable Milestone Event (each, a “Sales Milestone Notice”) within ten (10) Business Days after such occurrence.
(c) Royalties. During the Royalty Term, ALFASIGMA will pay IPI a royalty equal to 6% of the Net Sales, on a product-by-product, country-by-country basis, while and to the extent that the Compound or the Product is Covered by any IPI Patent (the “Royalty”, and together with the Initial Payment and the Milestone Payment, collectively, the “Consideration”), provided, however, that the Royalty shall be automatically, without action of any Party, reduced to 2% of the Net Sales if the Compound and/or the Product are not Covered by any IPI Patent or are otherwise Covered by a Joint Patent under Section 8.1(c).
(d) Royalty Reduction. Upon request of ALFASIGMA, the Parties acting in good faith shall negotiate a reduction of the Royalty rate set forth in Section 6.1(c), on a country-by-country and Product-by-Product basis, under general equitable standards, if following the entry into the market of any country of the ALFASIGMA Territory of a generic version of the Product by a Third Party (as determined by a reliable data source that is reasonably satisfactory to the Parties), the Product is no longer competitive in such market due to the then applicable Royalty rate. When negotiating a reduction to the applicable Royalty rate in accordance with this Section 6.1(d), the Parties shall use Commercially Reasonable Efforts to proportionately share equally the economic loss associated with any reduction in revenue, profitability, margins or similar financial metric, resulting from the entry of the generic version of the Product in the applicable country. For clarity, the term “generic version” is intended to refer to the entry of a true-generic version of the Product by a Third Party, and not merely a product competitive to the Product.
Kips Bay IS the other side of the series B-2 5% convertible preferred stock. These guys made a bundle!
From today's 10-Q:
On December 4, 2020, the Company entered into a securities purchase agreement (the “Series B-2 Securities Purchase Agreement”) with KIPS Bay Select LP for the sale of an aggregate of 5,089 shares of the Company’s Series B-2 5% convertible preferred stock (the “Series B-2 preferred stock”), for aggregate gross proceeds of approximately $5.0 million. An initial closing for the sale of 3,053 shares of the Series B-2 preferred stock closed on December 9, 2020 for aggregate gross proceeds of approximately $3.0 million, and a second closing for the sale of 2,036 shares of the Series B-2 preferred stock closed on February 8, 2021 for aggregate gross proceeds of approximately $2.0 million. Under the Series B-2 Securities Purchase Agreement, the Company will also issue to the investors warrants to purchase up to an additional 10,178 shares of preferred stock.
As of March 31, 2021, there are no shares of Series B-2 preferred stock outstanding and the series B-2 preferred stock liability is $0.
Would be good to know what "Non-clinical phase" under the column heading "Development stage at time of guidance" means. 21 of the treatments listed fall into this category.
I also find it interesting that Ivermectin is not on this list while chloroquine and Chloroquine and hydroxychloroquine cyclops DPI are.
Aspire's floor is a closing sale price of $0.10/share.
The Purchase Agreement provides that the Company and Aspire Capital shall not effect any sales under the Purchase Agreement on any purchase date where the closing sale price of the Company’s common stock is less than $0.10.
I have no problem with part of the trial being conducted in Russia, but I think you would have a hard time finding a trial by a US-based company that had such a high percentage of their sites in Russia. And for 1 out of 3 of the US sites and 2 of the Russian sites to still not be recruiting 8 weeks into the trial is not a good sign imo.
Here’s what IPIX said on October 2, 2020 about site selection and recruitment (Innovation Pharmaceuticals Announces Pre-IND Meeting Request Granted by FDA for the Study of Brilacidin for the Treatment of COVID-19).
Numerous hospitals and provider networks domestically and abroad have expressed a strong interest in participating in the Brilacidin for COVID-19 clinical trial. Given such interest in Brilacidin, the Company anticipates the planned COVID-19 trial can be rapidly recruited and completed.
e-Trade lists the top 3 owners of IPIX as:
Kips Bay, 5.13% (21.2 M shares)
Levison Resources, 4.14% (16 M shares)
Ehrlich (Leo), 2.53% (10.6 M shares)
Very surprised to see Levison on the list.
NOTE ABOUT % OWNERSHIP:
e-Trade shows 433.7 million shares outstanding for IPIX so Kips Bay % ownership should be less than 5%. Something is wrong with the percent calculation.
Smaller institutional owners are:
CAPTRUST Financial Advisors, 5k shares
CPS Investment Advisors, 12.5k shares
Independent Financial Partners, 56.1k shares
A poster wrote: "RVVT*** IS NOT currently in Clinical Trials AT ALL for Moderate to Severe Covid-19...in fact the press release to which you refer clearly states...it is in PRE-CLINICAL RESEARCH..."
I'm not going to predict success or failure, but Bucillamine does have a Phase 3 trial listed on clinicaltrials.gov for mild-moderate patients: Bucillamine in Treatment of Patients With COVID-19. It's enrolling 1,000 participants and has 27 study locations in the US.
HereToday, I think the link between Kips Bay and Leviston Resources was formed based upon the name of the person who signed the 13Gs. Whether that’s a good conclusion is debatable.
Leviston Resources: J. Miller
Kips Bay: John Miller
Definitely good news that Kips Bay has >21 million shares of IPIX.
Not such good news that out shares have gone up by nearly 36 million during the 47 business days from Feb 9 to April 19. IPIX shares closed at $0.38 on Feb 9th and $0.25 on April 19th.
One thing to keep in mind is that if Kips Bay is part of the preferred share deal they are entitled to a 5% annual dividend that is paid quarterly. IPIX would pay this dividend in shares.
I’m not “worried” about anything. I’m looking at what’s out there with logic and making decisions to increase (or preserve) my wealth. I function in the real world, not a world where a cabal of sorts is scheming to keep brilacidin away from the masses.
As to success or failure . . . IPIX and brilacidin have ample “thud” experience as they have been unable to get grants, partnerships, or any other sources of funding beyond diluting their existing shareholders.
A pill given to someone at the onset of COVID has no impact on brilacidin that's being tested in hospitalized patients? You're kidding, right?
At some point an investor needs to take a sober and unemotional view of what's happening in the real world. If the investor does their dd and still wants to put money on a speculative stock, that's their business. But it should be a rational decision, not based on fantasy.
Pfizer has one . . . Merck does too!
Another antiviral pill taking the focus off brilacidin. How Molnupiravir Moved to the Head of the 'COVID Pill' Pack | MedPage Today.
They’re in India too. MSD ties up with 5 Indian pharma majors for supply of oral COVID-19 drug Molnupiravir
ClinicalTrials.gov lists 5 clinical trials for Molnupiravir that are either recruiting or completed with more than 3,500 patients.
That’s tough competition for IPIX. IPIX has a single clinical trial of 120 patients that has been ongoing for nearly 2 months and has sites that haven’t even started recruiting.
What will the competitive landscape look like in July/August when IPIX finishes their trial?
Is this a milestone moment? Could it be that brilacidin has been given to more COVID patients than press releases issued about it by IPIX?
I would like to see an update to clinicaltrial.gov.
We’re entering the 8th week since the trial began (March 5th) and there is one site in the US and two sites in Russian that haven’t started recruiting. Not too long ago, there were posters on this board who suggested that the trial would be filled in a weekend. Remember that?
It's not "analysis". Here's what I wrote:
This is GMU's data. I'm just reading the data. As far as I know, it's the only data for brilacidin as an antiviral.
It's in the paper published in viruses in section 3.5. “Brilacidin in Combination with Other Antiviral Treatments: Synergistic Activity against SARS-CoV-2 in Combination with Remdesivir in Calu-3 Cells”.
Look at the table on the right in figure 5, part B for the % virus titer vs DMSO. It shows Rem 2.5 at 1% which means a 99% inhibition. Brilacidin is slightly less than 90% inhibition. If you read the PR put out by IPIX you would know nothing about the independent testing of remdisivir and brilacidin since IPIX only referenced the combined effect.
This is GMU's data. I'm just reading the data. As far as I know, it's the only data for brilacidin as an antiviral.
There was an interesting paper published in the journal viruses about brilacidin: Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture. The finding of nearly 100% viral reduction comes from section 3.5. “Brilacidin in Combination with Other Antiviral Treatments: Synergistic Activity against SARS-CoV-2 in Combination with Remdesivir in Calu-3 Cells”.
What some people miss is that GMU also provided data for remdesivir and brilacidin tested independently, not in combination. Same virus, same conditions, head-to-head. In those tests GMU demonstrated that remdesivir inhibited the virus by 99% by itself. Brilacidin demonstrated a lower inhibition. The testing done at GMU showed that remdesivir was more potent than brilacidin. This is inconvenient for investors in IPIX, including myself, but that is what GMU has shown us.
Some posters have been making the claim that remdesivir is “worthless” and a "fraud", yet the research done at GMU have shown it to be more potent than brilacidin. Was the research conducted at GMU corrupt? Is that why brilacidin will succeed where remdesivir failed?
I agree with your basic line of thinking. My specific interest, misplaced or not, is with kevetrin. A peer reviewed article on kevetrin was published in Oncology Reports in October ’20 (Kevetrin induces apoptosis in TP53 wild-type and mutant acute myeloid leukemia cells. IPIX issued an ok press release, then nothing.
The kevetrin research has been ongoing for a number of years. IPIX has been unable to generate any interest or put much money of their own into moving it forward.
Financing is definitely a problem. I don’t know where the figure of $16 million cash comes from (adding in the sale of all the preferred shares?). IPIX showed $8.2 million cash on the balance sheet in Dec 31st 10-Q. IPIX also listed contractual commitments of a minimum of $6.6 million that will be recognized as services are performed. The amount of cash on their balance sheet ($16 or $8.2 million) needs to be reduced by this amount to see what’s available.
From 10-Q
Contractual Commitments
The Company has total non-cancellable contractual minimum commitments of approximately $6.6 million to contract research organizations as of December 31, 2020. Expenses are recognized when services are performed by the contract research organizations.