The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
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.
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.
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.
Our objective for the remainder of the year is to convert as many of the 45 sites currently evaluating IB Software, to client status though sales and to harness the momentum from the Phase 1 clinical trial to accelerate the planning for a Phase 2 trial.
These are all quotes taken from the half year and final reports. Whatever happened to the 45 sites evaluating IB software? Either they’ve converted some into sales and not told us (ALL SHAREHOLDERS) or 45 sites said no. Since these comments the share price has fallen off a cliff and there’s obviously a reason but this reason is not being relayed to ALL SHAREHOLDERS. Why? I just don’t understand the games being played. We listed on the us market and had no interest because we didn’t do any pr at all. Now we’ve got the same problem. If you want to run this company as a private company then do it but you will have to buy us out first until then have some self respect and update your shareholders. I don’t understand publicly saying one thing and then doing the complete opposite. You are just making yourself look like a tit!!
Published - a practical guide for DSC-MRI perfusion imaging from the #SchmaindaLab at
@MedicalCollege
. Grateful to have such a DSC powerhouse in IB's corner!
https://www.frontiersin.org/articles/10.3389/fradi.2024.1307586
Al's Comment:
We awarded a $100,000 grant to get this expanded access program for oral gallium maltolate launched. I will let you know when it opens. We helped fund the early work on this drug and early results look good. If interested in trying to get access, send an email to eap@imagingbiometrics.com and tell them a little about your case and ask if you may qualify for the program and to get on the waiting list. Our grant only covers the startup of the program and the first 15 patients. If any other organizations want to help fund the next group of patients, contact me!
https://virtualtrials.org/newsarticle.cfm?item=8568
What I find strange is they completely ignore the fact about a partner for phase 2 which they have mentioned in the past. although they do mention
“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.”
Does this mean they’re going it alone?
It was good to get an update regarding IB zero also. But still strange they decided to release it on x on a Sunday night which probably means we won’t get an rns.
Tyke you’re missing this part
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.
Basically I interpret it to mean the data(results) from the early access program could be used instead of having to complete a phase 3 trial and even explains the fda have approved drugs solely from esp data.
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 agen
Congratulations to Dr. Mona Al-Gizawiy, PhD from the Schmainda Lab
at the Medical College of Wisconsin, for being awarded two grants
from The Advancing a Healthier Wisconsin (AHW) Endowment
(a statewide health improvement philanthropy). The two AHW
seed grants are for the following studies:
Developing a novel gallium compound for the treatment
of metastatic breast cancer
Characterization of response to Gallium Maltolate
in treatment-resistant Glioblastoma
Missed this also. I remember them tweeting she had got 2 grants but they didn’t say why now we know, just a bit strange that shareholders are only just finding this out by reading a document they haven’t promoted. As happy as I am that the share selling should now stop it would be nice to get someone running the company that has a clue about pr !
If you look at past issues there was a newsletter posted in December apparently. Did anyone else see this?
https://mcusercontent.com/ee2fb759d033ff87132180f83/files/423e2342-7696-d661-6e3c-49c091afdb31/December_2023_Newsletter.pdf
2m trade showing from yesterday must be one of the reasons for the drop and there must be more to come from today!
If it’s a placing being forward sold I will report those responsible for organising it and urge others to do the same.
Something not right here. No shareholder letter. The news yesterday could have been included in a shareholder letter. It would be nice if the directors here had some balls and offered some positivity to help stop the free fall through an interview or something to offer some reassurance!
It’s not much to ask for!
The major increase in share price will come from them announcing they have a large partner to fully fund phase 2 in my opinion. This is something they have already stated will happen. We still have the additional patient enrolment results and to see if they have found a maximum tolerated dose.
Again in my opinion, all the approvals we have received to date and to come from the FDA just validates the investment case for a large partner to jump on board. It’s interesting to think about how they will partner up ie licensing deals with milestones or an equity deal with the large pharma company taking a stake in the company or they could buy us outright.
We have a shareholder letter due going on last year’s letter at some point next week so it should be a good update and see what is planned for this year. They stated also they are applying for a large grant in February which is only a few weeks away so I’m interested to see what that entails.
Also we could hear at any point that they have started a phase 1 for paediatric patients which again they’ve already said they’ve been discussing with partners this and if so it would be fully funded.
So lots of other exciting things that could drastically improve our share price other than the voucher which they may not even need
GLA!!!
Goldman Sachs is planning to make a splash in the life sciences sector, taking in $650 million for its first fund aimed at the drug development space.
The size of the West Street Life Sciences I fund, which overshot its original target, makes it one of the largest first-time private life sciences growth funds, Goldman Sachs Asset Management claimed in a Jan. 3 release. The $650 million in equity commitments was drawn from a “global, diverse group of institutional, strategic and high net worth investors."
Around $90 million of the fund has already been parceled out to five companies in the group’s portfolio, including bladder cancer-focused Moma Therapeutics, molecular glue developer Nested Therapeutics and neurological disease biotech Rapport Therapeutics.
Goldman Sachs Asset Management has identified several themes of fundamental innovation as well as structural shifts that we believe will drive significant growth in the coming decades,” the firm said in the release. “These themes include precision medicine, genetic medicine, cell therapy, immunotherapy, synthetic biology, and artificial intelligence.”
Amit Sinha, head of the Life Sciences Investing Group, said the sector is entering a “golden era of innovation.”
“We believe the current environment provides an attractive opportunity for investing in the next generation of leading life sciences companies,” Sinha added. “Through our global platform, we seek to be a capital provider of choice and help our companies realize their full potential.”
Goldman Sachs' $650 million haul will offer some reassurance against a backdrop of declining fundraises for biopharma. An analysis by PitchBook in early December suggested that by the end of 2022, biopharmas were projected to have raised about $24 billion across about 840 transactions—the lowest tally in four years.
https://www.fiercebiotech.com/biotech/attractive-opportunity-investing-goldman-sachs-closes-650m-fund-aimed-biotechs
Could
NIMBLE app expected to be a game-changer for people with brain metastases
The Brain Metastasis Program and the NIMBLE app show promise as game-changers for physicians who need treatment options for their brain metastasis patients.
With NIMBLE, doctors can provide faster access to the experts and resources needed to treat brain metastases. Creating the app was central to launching the Brain Metastases Program and addressing the individual complexity of care for these patients. The NIMBLE app functions as a virtual tumor board that is always available for real-time, doctor-to-doctor discussions. With NIMBLE, the Froedtert & MCW team can offer data-driven treatment recommendations delivered within hours as opposed to days with references to data and publications that support those recommendations. NIMBLE is expected to make treatment options more accessible and to accelerate the treatment path for patients who need it."
While the team hasn't formally published research on the Brain Metastases Program or NIMBLE app, it submitted a paper late in 2019 to an MCW quality symposium. A preliminary study showed that with the expedited, data-driven approach offered by NIMBLE, the typical seven to eight day hospital stay for brain metastasis patients was reduced to about three days. Usually, such patients require involvement from many specialists, and it takes time for all of them to see patients in the hospital. NIMBLE guidance can help resolve this pause — and lower costs.
The app is the only one of its kind in the U.S. and will be available later in 2020 at no cost to physicians through app stores for iOS and Android platforms. NIMBLE offers unique benefits for brain metastasis patients and their doctors:
Decreases the wait: Patients and their doctors don't have to wait for the weekly in-person tumor board for a consultation
Offers immediate recommendations — in hours, not days
Expands resources for cancer providers caring for a brain metastasis patient
Provides a more streamlined path to treatment
Gives a second opinion without having to travel
Reduces hospital stay: For brain metastasis patients who have been admitted to the hospital, length of stay can be reduced by as much as seven days — no waiting for experts to gather to recommend treatment.