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As of March 31, 2021, we had approximately $13.0 million in cash compared to $6.0 million of cash as of June 30, 2020, and as of the date of this filing, we have approximately $12.1 million in cash. We currently anticipate that future budget expenditures will be approximately $10.6 million for the next 12 months, including approximately $8.3 million for clinical activities, supportive research, and drug product. Alternatively, if we decide to pursue a more aggressive plan with our clinical trials, we will require additional sources of capital during the fiscal year 2021 to meet our working capital requirements for our planned clinical trials. Potential sources for capital include grant funding for COVID-19 research and equity financings (see below). There can be no assurances that we will be successful in receiving any grant funding for our programs.
Thanks for the update. A bit disappointing as that is a slower pace than I'd anticipated but it could be worse. I'd guess 75% enrolled next week sometime given that info.
When does the reverse split take effect? Or is that no longer happening? TIA!
Enrollment should be hitting 75% complete soon - this week or next I'd imagine.
Any reason to think there's an impetus for IPIX to finish development of their Brilacidin pill, specifically for COVID?
I meant the next enrollment milestone PR. For example, I'd assume we'd be hitting 50% complete soon. I want to see when we are hitting these milestones so we know we're progressing and hopefully at a faster clip than it took to reach 25% enrolled.
Looking forward to the next PR indicating current enrollment % completed.
The website is scant, but in the EPIC meeting presentation BTO looked pretty good
Where is this from? TIA
By my rough estimation of enrolling 1.15 patients per day since trial start date on 2/22, we should be at ~30% enrolled by this point in time. By mid-April we should conservatively be 50% enrolled. Would be nice if they would PR some enrollment milestones such as these to inform the investment community of enrollment progress.
I'd also be very wary of attracting the Adam Feuersteins of the world...we don't want unsavory characters like those checking us out before we've managed to sign several deals. Their words, good and bad, can have a significant impact on a company still seeking their first revenues.
That's true we could hear about that...Wouldn't we want to stay at 3 days of dosing as it would indicate B is effective and fast? I understand 5 days would ensure more $$$ per course of treatment but this would be more onerous on the patient and less attractive overall. Of course, results trump everything but all considered I'd have to think we'd be hoping for the 3 day course to be enough as a major selling point.
Some metrics regarding enrollment speed. The PR on 3/5 indicated that they had dosed 15 patients since the start of the trial on 2/22. That's a little over 1 patient dosed per day. If we extend that same rate of new patient dosing, we would be at 22 - 24 patients dosed at this point and I would expect more than that have been dosed as they brought more sites online.
This would conservatively equate to roughly 20% of the 120 patient trial enrolled and dosing to date, with full enrollment being reached on June 12th. We should logically expect to come in well under this date as current and new sites get up to speed. Thoughts?
Great presentation. Even though it is pre-recorded, very glad to see Lebby doing the actual delivery of the presentation for the investment community. No offense to Marcelli, but Lebby is a much more polished speaker and better able to convey the promise and confidence that the company has in their tech.
This PR is more relevant than ever now with the new strains circulating. Would like to hear more from the company about the Pan-Coronavirus strategy but assume that info will come after the Phase 2 results:
November 30, 2020 - Innovation Pharmaceuticals COVID-19 Clinical Trial to Support Additional Development of Brilacidin as a “Pan-Coronavirus” Therapeutic. Additional independent preliminary laboratory research suggests Brilacidin, the Company’s flagship defensin mimetic, can 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.
I would love to see a corporate update that clearly states which of LWLG's products are ready for commercialization, via any method (direct sales, licensing, tech transfer, etc) and which are still in development. Maybe a case study on the positive impacts of Lightwave's technology on undisclosed testing partners' products thus far. Something that could be used in a salesy type of way to let everyone know they are truly open for business.
We continue to hear plenty about data, IP, and industry roadmaps which are all super important but it'd be great to see some ramped up marketing efforts to the industry in general (I understand the recent conference was intended for this purpose) along with the investment community. It still kind of feels like we're operating in semi-secret based on news flow out of the company lately.
Ha! Love it.
Who knows, maybe Lebby was trying to spice up his delivery and wrote down phonetically how he intended to pronounce it ;)
If anyone speaks to Karen again, there is a typo on slide 3:
We enable faster networks.
Our robust, stable chromophore family of
materials allows network architects to
squeeze more performance from existing
network infrastructure at 70GHz and
beyound.
https://www.lightwavelogic.com/wp-content/uploads/sites/319/2021/02/Lebby__Photonics_Plus_for-web.pdf
Thanks for reaching our to Karen and clarifying on that point Steve - they would do well to clarify that on the slides as it gives the wrong impression that the issue is on our end IMO.
From Slide 7 - looks like we are still working to overcome one barrier for the Polymer Slot product but the other 2 products seem ready for commercialization?:
"Polymer Slot -smallest form factor. Optical coupling needs to be improved."
My understanding from someone in drug development is that American pharma companies will often expand trials in Europe when there is fierce competition for patients at home. We are certainly competing with a lot of other companies and trials for our patients so this makes sense for IPIX in the interest of time and data.
If there is indeed an interim data look incorporated into the trial design, perhaps that is part of the delayed filing if we did begin enrolling/treating patients in January?
Assuming the worst (trial hasn't started) but hoping we get surprised with a "full enrollment" PR that starts the count down to results....a little wishful thinking for a Friday
Agree, this hurts IPIX but then again will budesonide be effective against mutant variants and other types of Coronavirus, etc?
Fantastic summary of the current state of affairs, thank you! And 2023 is really not too far away now if they truly believe they will be asking for regulatory approval that year in North America. Promising!
Hopefully it will be in need of some updating soon as/when more news comes out.
New investor presentation this year from January 2021 on the website:
https://www.lightwavelogic.com/investors/
Has this been discussed? Maybe I'm late to notice.
So what's next here? Patient enrollment? TIA!
What's next here? Uplisting (R/S or not)? Commercialization/sales? Corporate Update?
TIA!
So at this point, what is the most prudent way to get on a higher exchange and finally graduate from the OTC. I assume being on a higher exchange will facilitate more investment in IPIX...
Does it make sense to wait on trial results and hope it happens organically pending positive results? R/S at these higher share prices in the meantime and hope for a bigger bang upon receipt of presumed positive trials results?
Any thoughts on best strategic course of action for the company?
First Patient Dosed - Is this the next PR we're looking for? That would seem logical to me but perhaps there's another step in between?
Someone mentioned within the last couple of days that there is one more issue being worked on currently by LWLG and potential partners. It was not stability, but something else, possibly related to connecting devices.
Does this ring a bell and would anyone care to elaborate on where/when that was noted by LWLG? TIA
"...but the FDA held back until today..."
So, I'm unclear on the message here. Is he implying there is no reason the current administration will take an interest in Brilacidin because it is not in time for re-election efforts/news cycle? What are folks inferring from this?
Haven't watched it myself.
Has anyone suggested to Lightwave that Karen take on this presenting role?
She should be qualified to handle that and some of the more technical pieces with her background and skillset.
On a related note, and this is may have been mentioned, but from the LWLG website they seem to be alluding to potential increased integration opportunities with Silicon technologies:
https://www.lightwavelogic.com/technology/our-technology/
P2IC™ (Polymer Photonic Integrated Circuits) are ideally positioned to be one of these new technologies. Lightwave Logic’s devices are made using conventional wafer-scale processing such as used for microelectronics and therefore similarly capable of being integrated. In addition, the polymer microfabrication processes are compatible with other materials platforms such as Silicon Photonics and Indium Phosphide which are now starting to become more integrated. In particular, the Silicon Photonics ecosystem has recently accepted that its roadmap will include adding more and more materials, each for their specific benefits. EO polymers’ speed and voltage advantages are attractive additions to this ecosystem.
Per the GMU testing, it seems the research will end in late August per the below PR snip. Hopefully we have news before then but looks like we're about a month out for these testing results:
"As part of this project, Narayanan will first determine the EC50 values, or the concentration of the drug that gives a half-maximal response.
From there, Naryanan and her collaborators will evaluate if Brilacidin has direct virus-killing activity.
They will also assess whether Brilacidin can be provided as a second dose to infected cells without inducing toxicity.
As they work, the researchers will time their experiments to determine the appropriate timing of treatment.
Funding for this research began in May 2020 and will conclude in late August 2020."
insert-text-here
Savvy PR move (and great news in general) - this will garner the attention of anyone searching the news for "remdesivir" so we should have some new interest and eyes on us...
Does the link/info disclose what the size of the grant requested is? (in $$$)
Given that the study at George Mason University is schedule to wrap up in late August, I have to imagine they will be filing their IND in late August as well, or perhaps early September?
From the PR today:
"... the Company is looking to start a clinical trial with Brilacidin for COVID-19 treatment in Q4 2020. This forecast assumes manufacturing is completed, per the manufacturer’s timeline, and a successful Investigational New Drug (IND) application with the Food and Drug Administration."
New June 2020 corporate overview slides highlighting COVID 19 potential, and next steps for B - IBD Oral delivery. Not sure if this has already been shared:
https://static1.squarespace.com/static/5715352e20c647639137f992/t/5ef52e8642e893359052ad10/1593126540921/IPIX+Corporate+Overview+June+2020+fv.pdf
Wouldn't it then almost be smarter for Cisco to buyout LWLG so they can sit on the tech while getting their ROI before rolling out Polymers that nobody else can compete with?