Ryan Mee, CEO of Fulcrum Metals, reviews FY23 and progress on the Gold Tailings Hub in Canada. Watch the video here.
The de novo request is a market clearance pathway designed for novel medical devices for which no legally marketed predicate device exists to demonstrate substantial equivalence. So we could receive an update on this imminently also.
#IQAI shares have previously traded as high as 24p and as low as 1p with all this recent positive news announced they could in my opinion be headed back to 20p+ although this time they have a dual listing on the us otc market so we could see new all time highs if it gets picked up over there with the us investors having deeper pockets. There are 183m shares in issue and the ceo holds 29% of these so it’s in his best interest for these to succeed. Currently shares are 3.8/4p giving a market capitalisation of £6.9m. With all these factors and with their footprint in the USA only getting bigger and deals being signed better this share will in my opinion be multiples of today’s price in the very near future.
#IQAI #stockpick
Numbers are end of June..
Cash 90k
Income 282k
Profit 278k
Costs 578k (Admin 572k, Finance 5k etc)
Loss 300k
Cash used in operations is 224k.
More than 45 different hospitals and healthcare systems are at varying stages of evaluating our software, with more sites entering the sales pipeline. This step-change in pre-sales activity is approximately a seven-fold increase over previous periods and is due, in large part, to the traction gained from our platform partners including TeraRecon (Eureka) and Bayer (Calantic). These partners have the medical expertise and marketing reach to sell our technologies into large existing installed customer bases and have ample sales and marketing resources to win clients.
It is a relatively easy up-sell for IB's partners' sales teams to activate IB's technology on platforms already being used clinically. The number of sites evaluating our software continues to increase. Thus, we are optimistic about the revenue activity and anticipate a step-change starting in the 2nd half of 2023. Plus we now have the GE health care network to sell into. GE Health has installed 4 million scanners and other medical devices worldwide. GEHC total assets $28bil. They invest over $1bil annually in R&D. 259k patients supported daily using imaging technology. 2bil patients scanned annually.
Lots to look forward to in regards to upcoming updates
#IQAI On Friday afternoon announced a deal for IB Neuro and IB Delta T1 to be embedded in GE HealthCare's (GEHC) MR Smart Subscription. IB Neuro and IB Delta T1 maps are applications that accept magnetic resonance imaging (MRI) data as input and automatically compute quantitative and proprietary images as output.
The global MRI market is projected to grow at a rate of 7% and surpass $11 billion by 2030, and GEHC is a leading player in that market. A factor driving that growth are complementary advancements in imaging software, such as IB's quantitative solutions.
Their software is available via the newly launched Bayer Calantic platform.
They also have a drug in phase 1 but have already stated it will be entering phase 2 and this will be funded by a partnership with a major pharmaceutical company. They have recently received orphan drug status for this drug for both adult patients and children for the treatment of glioblastoma(brain cancer). They have recently announced they will be starting a second phase 1 study for children and have initiated discussions with several sites who have expressed a collaborative interest. Paediatric brain tumour research and development receive significant philanthropic funding. Consortiums of non-profits exist that help fund clinical trials for children, either partially or in their entirety. #IQAI have already made connections and introduced their progress to one organization. In turn, they identified several hospitals with whom they have established relationships so we should receive an update imminently for this. The ultimate objective of our program is to obtain regulatory approval for a medicine that could offer a positive impact on the length and quality of life for patients who otherwise have no other options. As the trial process continues, their efforts to identify and secure an accelerated regulatory approval pathway will also continue. Pathways, such as Fast Track Designation and Paediatric Rare Disease Priority Review Voucher (PRD-PRV), exist to expedite the development, review, and approval of promising drugs that treat diseases such as GBM and paediatric cancers.
Paediatric rare disease priority review vouchers have recently sold for over $100m with examples from Sarepta Therapeutics and bluebird bio both selling theirs to major pharmaceutical companies.
#IQAI Also have patented artificial intelligence ("AI") technology, IB Zero G generates enhanced "with contrast" images using only non-contrast (0% gadolinium) images as input. The FDA's response to the FDA 510(k) submission concluded that IB Zero G™ was too novel and unique a product and subsequently directed IB to pursue a different regulatory clearance pathway. IB is compiling additional documentation in preparation for a pre-submission meeting with the FDA and plans to submit a "de novo" application in the second half of the year. The de novo request is a market clearance pathway designed for novel medical devices for which n
Just rereading the report from this morning and this part stood out
“we are considering a phase 1 study in children and have initiated discussions with several sites who have expressed a collaborative interest. In addition, paediatric brain tumour research and development receive significant philanthropic funding. Consortiums of non-profits exist that help fund clinical trials for children, either partially or in their entirety. We have already made connections and introduced our progress to one organization. In turn, they identified several hospitals with whom they have established relationships.”
If you look at the top right corner of the poster titled Gallium Maltolate as Treatment for Pediatric Glioma it has the “macc fund” and “childrens hospital of Wisconsin could these be the organisations mentioned? Either way it shouldn’t be too much longer for an update on this if they have already started discussions
https://www.gallixa.com/GAMReferences/MolinoEtAl2019PedGlioma.pdf
Tb is the biggest shareholder so stands to lose the most if this fails and on the other side he will get the biggest gain if it’s a success hence the reason he’s happy to fund until the business is completely organic with growth they mentioned today that phase 2 will require the backing of a partner to fund which is great news. With all the benefits that come with orphan drug status it wouldn’t surprise me if they get bought out completely.
GLA!!
Here’s the link
https://www.iqai.ltd/
If you go to the bottom of imaging biometrics website then click the investor information tab it should take you to the link provided
Here is where you will find it’s still active
https://www.jerseyfsc.org/registry/registry-entities/entity/184638
They’re 2 completely different drugs / products/ companies and if they both fail phase 3 then that’s it but with Iqai they have multiple potential revenue streams from drugs to mri techniques to artificial intelligence software. One of the main reasons I’ve always been invested in this is because of Kathleen. Imagining biometrics doesn’t exist without her input it’s all her hard work over the years and the fact that her and Michael have large stakes in Iqai means they will eventually be rewarded for their hard work as well as tb for funding them.
One thing’s for sure. When this hit 20 odd p last time it was hovering around the 3.5/4.6 range then in a couple of days it went mental.
This time round we are dual listed on the otc market where share prices can and have done 1000% in a day. So I’m hedging my bets that once value is seen across the pond they will chase this up big time.
The catalyst could come from multiple avenues.
GLA!!
Ps that was my buy last week 649766 I’ve been busy so haven’t had much time to check in here.
a phase i study of a new drug candidate for high grade brain tumors. (gallium maltolate)
very interesting comments made at the end in regards to the promising pathway act.
https://www.congress.gov/bill/117th-congress/senate-bill/1644
“the biggest thing we’ve ever worked on is called the promising pathway act. it’s a new law designed to take drugs like what you’re talking about and get them to patients much quicker. basically we’ll do away with the need for a phase 3 trial and you’ll get a conditional approval after phase 2. you’ll cut off 95% of developing the drug but in return every patient that uses the drug while it’s conditionally approved has to be followed in a registry as if they’re in a clinical trial” ….. then goes on to explain that the brain cancer foundation could fund further development of the drug eliminating the need for the company to raise 50 odd million for a phase 3. that way they could bring to market 5/10 new drugs a year to be able to see all the interactions between the drugs to help figure out the best ****tails. dr chitambar also replied he would like to learn a lot about that. watch from 58minutes.46seconds
https://www.youtube.com/watch?v=ks_xkt3yr6k
Following a successful appearance at the ASNR (American Society of Neuroradiology) conference in Chicago earlier this month, Imaging Biometrics LLC ("IB") is exploring two academic collaborations for the commercialization of novel and emerging imaging technologies.
The Phase I clinical trial maintains strong momentum, enrolling subjects at the final dose level and into the expansion phase (where a larger number of patients are treated to further assess the safety of the final dose).
Over 200 more datasets have been received in collaboration with Phoenix Children's Hospital. These datasets will be used for the continued development of Artificial Intelligence (AI) imaging technologies targeted to aid pediatric patients. Quality training data improves AI performance and the AI models already in development for adult patients can easily be trained using pediatric datasets.
A product development milestone was met for enabling longitudinal reporting capabilities. This accomplishment lays the foundation for reporting of IB's quantitative output over time to assess treatment response in patients.
IQ-AI is an ideas incubator, a creative collaboration of dedicated medical scientists, clinicians, and software developers who are originating solutions and tools which are having a growing impact on the treatment and management of one of the most intractable cancers.
The key drivers are all shareholders, who have had to become accustomed to the vagaries of the stock market and how it values the Company`s shares. Oftentimes the market capitalization of the Company has changed over a small number of trading days by 10-25% without any discernable reason, however we remain firmly focused on the medium-term commercial prospects for our unique products and are confident that shareholder patience will be eventually rewarded. We will not deviate from our central aim of achieving commercial and medical success.
It is five years since IQ-AI acquired Imaging Biometrics. Throughout that time the IB team have worked continuously and intensively to innovate and develop what has now become a valuable portfolio of medical IP. We believe that the cumulative accretion of value during this time is not adequately reflected in the current market valuation of the Company, and we are now considering how best to address this anomaly.
The phase I clinical trial for oral gallium maltolate ("GaM") continues to track ahead of schedule. Orphan Drug Designation status has been granted to Imagining Biometrics ("IB") by the FDA. This designation offers several significant advantages to the Company including seven years market exclusivity post market approval, and reduced FDA fees
The Company submitted its second Orphan Drug Designation request to the FDA for treating pediatric brain tumors with GaM. A decision is expected by early Q3. Motivation for this request was generated from two landmark pre-clinical studies completed by Dr. Mona Al-Gizawiy, PhD in the laboratory of Dr. Kathleen Schmainda, PhD at MCW. These studies demonstrated similar remarkable results of GaM in atypical teratoid/rhabdoid tumor (ATRT) and GBM in children as it did in the pre-clinical study for adult GBM. Current treatment protocols for pediatric brain tumors subject children to the same toxic, invasive, and harsh treatment protocols used to treat adult brain tumors.
The Company recognizes the interest and willingness of the FDA and the National Institutes of Health ("NIH") to help companies accelerate the delivery of promising new treatments to these patients and intends to form a close working relationship with the agencies in the coming months.
New Studies Show Oral Gallium Maltolate (GaM) Inhibits Pediatric Tumor Growth
Imaging Biometrics, LLC (IB), a wholly-owned subsidiary of IQ-AI Ltd (LSE: IQAI, OTCQB: IQAIF), is pleased to share the results of two pre-clinical studies that were presented at last week's 2023 Society of Neuro Oncology (SNO) Pediatric Conference in Washington, DC. Each study, led by Dr. Mona Al-Gizawiy, PhD from the Schmainda Lab at the Medical College of Wisconsin (MCW), demonstrated inhibitory effects of oral GaM in two types of pediatric brain tumors in vivo; atypical teratoid rhabdoid tumor (ATRT) and glioblastoma multiforme (GBM). Oral GaM is the same agent being investigated in adult GBM in IQ-AI's sponsored phase I clinical trial being conducted at MCW.
In 2022, it was estimated that approximately 5,500 new cases of brain tumors were diagnosed in children age 0-19 in the US. While rare, brain and other central nervous system (CNS) tumors still represent the largest cause of cancer-related death in that age group. Both ATRT and GBM are highly aggressive tumors that are associated with poor outcomes in children. The dire prognosis is due in part to the poor response to limited treatment options available.
The results of each study were consistent with previous in vitro work conducted in the Schmainda Lab showing tumor growth inhibition and a survival benefit from treatment with oral GaM. Median overall survival for ATRT was 89 days in the control group and 170 days in the treated group. For GBM, those numbers were 21 and 49 days, respectively. Both studies concluded that monotherapy with oral GaM profoundly inhibited growth and provided a significant survival benefit.
In April, IB applied for Orphan Drug Designation to the US Food and Drug Administration (FDA) for the use of GaM in pediatric brain tumors. The application is under review and, if granted, would support the development and evaluation of a new treatment alternative for an unmet clinical need.
New article
Clinical trial in Wisconsin looks to trick brain cancer cells, slow tumor growth
A clinical trial in Wisconsin offers new hope to patients with a rare form of brain cancer.
Researchers in Wisconsin are using a chemical element to trick brain cancer cells and slow tumor growth.
https://spectrumnews1.com/wi/milwaukee/news/2023/06/16/clinical-trial-in-wisconsin-looks-to-tricks-brain-cancer-cells--slow-tumor-growth