Iq-ai Share Discussion Threads

[festario] 24/1/2024 10:37

Who knows. This stock, despite supposedly being on main market, and therefore immune to the AIM shenanigans has been manipulated shamelessly over the years. Just look at the latest letter to shareholders, I'm a shareholder, but if I'm not on Twitter I don't get to see it. The corporate governance on this stock has been woeful.

[clocktower] 24/1/2024 10:33

Funding F?

[festario] 24/1/2024 08:42

Bouncy bouncy

[albert35911] 23/1/2024 18:05

Tooooo right

[festario] 22/1/2024 16:52

So, assuming FAB are clearing down to zero, there will be another approximately 8m shares worth of dumping to suffer before we have a ‘clean edge’

I don’t believe there is a buyer for them, because if there was, they could do this off market, and the price wouldn’t get hammered like this.
It’s just us idiots, thinking we have a good buying opportunity at every descending level, but it proves to be nothing but a falling knife.

[festario] 22/1/2024 16:08

He's not even checked to see if this is on the AIM exchange, which of course it isn't.

[albert35911] 22/1/2024 15:05

Likes to go down does this share,really fun watching people trying to talk it up.

[clocktower] 22/1/2024 10:30

TB wipes the board clean again and again.

[clocktower] 22/1/2024 08:37

I don’t think the letter will save it from further decline at present, until we know how further funding is going to be achieved, the trend is your friend impo.
DYOR

[howdlep] 21/1/2024 19:41

Thanks Spurs.

A strange time to bring out the comprehensive Letter to Shareholders but it certain gives us plenty of time to read it before tomorrow's open.

[spurs90] 21/1/2024 19:26

Dear Shareholders,
As we embark on a new year, I am pleased to provide this summary to you. In it you will find highlights
from 2023 and our plans for Q1, 2024.
Clinical Trial Update
The phase 1 trial being conducted at the Medical College of Wisconsin (MCW) continues to warrant our
full attention. Patients are enrolling at the 2000 mg dose level and are experiencing no significant side
effects. The goal of phase 1 is still unmet in that the maximum tolerated dose (MTD) has yet to be
determined. The clinical team is reviewing all data and discussing what, if any, criteria could be used in
lieu of MTD to define the recommended phase 2 dose (RP2D). This would then result in phase 1 being
closed and allow the preparation for a phase 2 trial to hit full stride.
While the phase 1 trial maintains momentum, significant regulatory milestones have been achieved that
formally validate the promising potential of GaM (as well as remind us of the lack of viable treatment
alternatives for brain tumor patients). In late December, the FDA designated the development of oral GaM
for the “treatment of adult patients with relapsed or refractory glioblastoma, IDH-wildtype” as Fast Track.
The Fast Track Designation (FTD) process facilitates the development of new drugs that treat serious
conditions and fill unmet clinical needs. Going forward, we intend to fully leverage the increased
communication and collaboration with the US FDA afforded by this process.
Along with the two Orphan Drug Designations (ODD) received last year, these regulatory
accomplishments have boosted the enthusiasm of our internal team and that of the leadership at the
Medical College of Wisconsin (MCW). Motivated by these accomplishments, we are launching an
Expanded Access Program (EAP). The benefits of an EAP are multi-faceted, and I will touch upon a few
significant ones here. First, the agent itself is very stable and does not require special storage or
handling. Thus, an oral agent that can be taken at home is an ideal candidate for executing an EAP.
Second, the EAP would make the agent accessible to patients throughout the U.S. and allow patients to
obtain GaM who otherwise could not participate, due to proximity to MCW or the inclusion/exclusion
criteria of the phase 1, etc. Based on the data obtained from phase 1, albeit limited, we believe the agent
has potential benefit for these patients. Third, additional data from the EAP would be obtained faster than
the traditional phased trial pathway and would be considered “real-world-data” (RWD). RWD is
increasingly valued as it is a truer representation of the normal population of patients. RWD can also
identify critical information, such as biomarkers, that can significantly influence the size, scope, and cost
of subsequent phases. This data could then be used in a New Drug Application (NDA) to the FDA. In fact,
there have been agents approved by the FDA that relied solely on EAP data, and even more agents
whose approval relied primarily on data obtained from EAPs. Finally, as part of the EAP, we will qualify a
2nd source of supply of GaM. This is an FDA requirement necessary for commercialization.
We have an opportunity to help patients that are in dire need of treatment alternatives. We also have an
opportunity to obtain quality data necessary for final FDA review and approval much faster than typical
drug development timelines (which can last well over a decade). The FDA does allow direct costs to be
recovered under an EAP. As an unapproved agent, patients would have to incur the direct costs of
receiving the agent and we are aggressively working to make this as affordable as possible.
On the horizon is a decision to be made by the Office of Orphan Product Development (OOPD) regarding
our Pediatric Rare Disease (PRD) designation request. We anticipate a decision will be made by mid Q1
assuming that no (or few) requests for additional information are received by the OOPD. As previously
communicated, two pre-clinical studies were conducted in the laboratory of Dr. Kathleen Schmainda,
PhD, of MCW, each led by Dr. Mona Al-Gizawiy, PhD, which have demonstrated overall survival (OS)
benefit in preclinical models of two pediatric cancers (GBM and atypical teratoid rhabdoid tumor, or
ATRT). These two studies provided the data to support the ODD designations received earlier in the year.
This data was also integral to the PRD designation request. If granted PRD designation and GaM
receives FDA approval, the FDA may award us a priority review voucher (PRV) which can be redeemed
(for the review of a subsequent new drug application) or sold to another sponsor. There are no active
phase 1 trials studying GaM in pediatric brain tumor patients. There is also limited toxicology or dosing
levels identified for children. There is a possibility, however, that an EAP could be launched to provide
access to GaM for pediatric patients. We intend to explore that option as we move forward with our
planned EAP.
Overall, the core team celebrated many milestones in 2023. All those milestones were reflected in long
hours, scientific discovery, and ultimately a passion to help patients.
Our Focus in 2024
Our core imaging business remains our backbone, however, we must stay focused on the continued
advancement of oral GaM for cancer patients. The promise of delivering an effective cancer treatment
command us to do so. That said, we are acutely aware of the lengthy development timelines associated
with pharmaceutical agents and look forward to working closely with the FDA via the Fast Track
Designation process and bringing this to market as soon as possible. In the interim, increasing sales
revenue of our imaging products is pivotal.
We will continue supporting our major channel partners, whether through technical support and
troubleshooting or joint marketing and sales efforts. We are also committed to releasing automated
“fractional tumor burden” (FTB) mapping which will provide an attractive upgrade for existing clients and
an incentive for new clients to adopt. We anticipate having the initial version ready for demonstration at
the annual American Society of Functional Neuroradiology meeting in August. Likewise, our efforts to
implement longitudinal reporting capabilities continue and may be ready at that time. Recently, IB Nimble
has received the attention of our development team as we continue to “industrialize” the code base
adopted when we licensed the application. This work includes incorporating enhancements requested by
current and prospective users.
Our IB User’s Group webinars will continue. On deck at the end of January is Dr. Joe Bovi, MD, who will
discuss the clinical utility of IB Nimble. And our collaborative relationship with Phoenix Children’s Hospital
(PCH) has culminated in a planned study using output generated from IB Zero G. The tentative plans are
to have two to three experienced pediatric neuroradiologists compare IB Zero G’s output against real
“ground truth” images. Depending on the results and feedback from the clinicians, a 510(k) submission
may be prepared with revised indications for use (IFU) specific to pediatric patients. Finally, every
indication is that a phase 2 trial is imminent, and we are preparing to continue our sponsorship. We will be
working very closely with the clinical team as they define the protocol and size of phase 2 and identify
other participating sites. There will be a gap between the conclusion of phase 1 and phase 2. Data
analysis and documentation needs to be submitted to the FDA and the phase 2 protocol needs FDA
approval. This makes an EAP even more strategic as it enables an aggressive pathway to continue our
efforts towards full commercialization.
Other Updates
Since submitting our Current Procedure Terminology (CPT) code application to the American Medical
Association in November, we have had multiple productive exchanges with the CPT Editorial Panel.
Based on their excellent feedback and guidance regarding our code change application, we decided to
revise and resubmit the application later this year. Specifically, and as suggested, the revised application
will incorporate additional feedback from content experts and specialty societies such as the American
Society of Neuroradiology, the American College of Radiology, and others. We will also focus on the post-
processing component and forgo the acquisition of the data, which was determined to be covered under
an existing CPT code.
Sincerely yours,
Michael Schmainda,
CEO, Imaging Biometrics, LLC
Director IQ-AI Ltd
The Directors of the Company accept responsibility for the content

[albert35911] 19/1/2024 17:36

A sea of red thumbs down,very similar to the sea of red with this dog of a share,which some would have you believe it’s a pedigree,eh festy.

[albert35911] 19/1/2024 16:24

Felty is reading my posts he marked me down.TutTut

[albert35911] 19/1/2024 15:53

Into the 2p realm next week,will it be before Wednesday.Ain’t life tough having to admit to yourselves you got taken in by the pumpers,still look at it as good experience.

[clocktower] 19/1/2024 10:10

Someones got to line their greedy pockets F.

[festario] 19/1/2024 10:04

Brutal, 40% down in less than 2 weeks. These guys really know how to manage shareholder values don't they?

[clocktower] 19/1/2024 08:32

More likely that a whole new funding round and warrants to go with it.

I look forward to it F if so, as I am currently cash rich and holding minimal stock.

[festario] 18/1/2024 20:00

Maybe the sell off today heralds bad news on the progress of the FDA fast track application? Maybe, just maybe, it's been declined, and it's leaked to someone with a sizeable holding?

[festario] 18/1/2024 18:08

The buys in the last hour all got slightly cheaper, which suggests that even more was being sold behind the scenes. Sadly that will lead to a further drop in the share price in the morning.Whoever the seller is, Trevor, FAB or some other large holder, they see no value in this stock, even at 3p

[albert35911] 18/1/2024 16:31

Plenty to go yet,the wrong momentum ie down.festy would know about that with his £200 worth.

[clocktower] 18/1/2024 16:25

Maybe you should now buy on the dip albert, while still on offer at 3.5p Bargain.