Member Info for Dmac1966

As of January 2026, there is significant momentum for Gallium Maltolate (GaM), particularly following the successful wrap-up of the Phase 1 adult trial and the recent launch of a major pediatric study.

Imaging Biometrics (IB) is positioning GaM as a "mechanism-driven" therapy that starves brain tumors of iron. Here is the latest progress for both adult and pediatric applications: 

1. Adult Progress: Recurrent Glioblastoma (GBM)

The adult Phase 1 trial (NCT04319276) reached a major milestone in late November 2025. 

• Completion of Phase 1: The study officially met all safety and pharmacokinetic targets. Out of 26 participants, 22 were evaluable for efficacy, showing no significant adverse events. 

• Survival Signals: Preliminary data reported in April 2025 showed an overall survival of 14 months from the start of GaM treatment (compared to the historical benchmark of 8–9 months for recurrent GBM). 

• Imaging Breakthrough: IB is utilizing its proprietary Fractional Tumor Burden (FTB) mapping to better distinguish between actual tumor growth and "pseudo-progression" (treatment-induced swelling), which has historically been a major hurdle in GBM trials.

• Next Steps: The company is currently preparing to initiate Phase 2 trials in early 2026 to focus on efficacy and optimal dosing. 

2. Pediatric Progress: The "GABRIEL" Trial

There is a fresh and significant development for pediatric use as of this week:

• Trial Launch: A new Phase 1 trial titled GABRIEL (NCT07331064) was first posted on January 9, 2026. It focuses on pediatric patients (ages 0–17) with Relapsed/Refractory High-Grade Glioma and Atypical Teratoid Rhabdoid Tumor (ATRT). 

• Estimated Start: Recruitment is expected to begin around May 15, 2026. 

• Strategic Designations: GaM already holds FDA Rare Pediatric Disease Designations (RPDD) for both pediatric GBM and ATRT.

3. The Impact of the Legislation Block

The "Give Kids a Chance Act" delay directly affects the Priority Review Voucher (PRV) associated with these pediatric designations:

• The Risk: Since IB-003 (GaM) has the RPDD, it is eligible for a PRV upon approval. These vouchers are currently worth $100M–$160M. 

• The Deadline: Under current law, GaM must be approved by September 30, 2026, to receive the voucher. If the Senate block continues and the program "sunsets," IB could lose out on this massive non-dilutive funding source unless the legislation is passed retroactively or extended before that deadline. 

• Breakthrough Status: In June 2025, the FDA encouraged IB to "withdraw and resubmit" their Breakthrough Therapy Designation to include more mature data. The company is using the recent Phase 1 completion data to strengthen this resubmission. 

Summary Table

The situation in the Senate is currently a high-stakes "legislative hostage" scenario. While the bill itself has near-universal support, it has become a bargaining chip in a larger battle over healthcare funding.

Why it is being blocked

The primary obstacle is Senator Bernie Sanders, who blocked a "unanimous consent" request to pass the bill in late December 2025. 

• The Leverage Play: Senator Sanders does not actually oppose the Give Kids a Chance Act. Instead, he is using it as leverage to force a vote on a much larger healthcare package, specifically seeking billions in funding for Community Health Centers.

• The Counter-Block: In a surprising turn, Senator Markwayne Mullin (the bill's lead Republican sponsor) also voted "Nay" on a version that included Sanders' amendments. Mullin argued that while he supports health centers, the PRV program shouldn't be "held hostage" by a multi-billion dollar spending request that hasn't been properly funded (or "paid for"). 

• The "Grinch" Feud: This led to a public spat where Mullin labeled Sanders "The Grinch" for blocking a bill named after a child who passed away from cancer. 

Will this be resolved?

Most legislative analysts believe it will be resolved, but likely not as a standalone bill. Here is how it is expected to play out:

1. The "Must-Pass" Vehicle: Historically, the PRV program is rarely passed on its own. It is typically tucked into a larger "must-pass" spending bill (like a Continuing Resolution or an Omnibus) where both parties can claim a win.

2. Pressure from the White House: The current administration (HHS) has publicly backed the bill. If the "sunset" of the program begins to visibly stall pediatric cancer trials, the political pressure on the Senate to stop the infighting will increase significantly.

3. The 2026 Deadline: The real "hard" deadline is September 30, 2026. This is when the authority to award vouchers for existing designations expires. To avoid a total collapse of the market value for these vouchers, Congress usually acts before the summer recess (July/August). 

Current Outlook

For now, the program remains in a "lapsed" state for new applications. If you are tracking this for investment or pension purposes (given your interest in emerging markets and market stability), this legislative stall is currently contributing to the "uncertainty" in the mid-cap biotech sector.

Hi both,

Speyside will get permission any borehole depresses the groundwater in the alluvial gravels and that can affect salmanoid streams that feed the spey. Non- negotiable. They will need to find alternative water source. The traffic will be accepted as they are ultimately going to build a local hydrogen piped network to the main distillery hubs that will reduce traffic (not tied into Project Union).

Scotland will have an AI backbone across the central belt with all those universities located there. Not quite London, Cambridge and Oxford but still not bad hub area.

We might also have hydrogen trains Inverness wick and Glasgow Mallaig lines, cho, cho. The prototype fuel cell train is passing through my station 12.15 tomorrow.

We appear to have missed out, perhaps deliberately, on the glass and ceramics industry in the short term.

The substantial green ammonia fertiliser plant at Nigg will likely not use PEM.

As of late 2025, there are 51 active distilleries in the Speyside region—representing one-third of all Scottish distilleries. Because these sites account for roughly 45% of Moray’s fossil fuel demand, converting them to green hydrogen is a massive technical undertaking.

The Hydrogen Requirement

To fully decarbonize Speyside's whisky production:

• Energy Demand: Research from Element Energy identifies distilleries as the UK's third-largest industrial hydrogen demand source, requiring approximately 1.4 TWh annually for the entire Scottish sector.

• Speyside Share: To meet the industry's 2040 Net Zero target, Speyside alone would require roughly 0.8–1 TWh of green hydrogen.

• Infrastructure Needed: This would require a total electrolysis capacity of 300 MW to 400 MW—far exceeding current pilots.

The 2025 Solution: Storegga’s Hub

The Speyside Hydrogen project at Ballindalloch is the primary answer. By 2032, this hub aims to scale to 200 MW, producing enough fuel to save 190,000 tonnes of CO_2 per year. Currently, its phased rollout (starting with 70 MW) is designed to serve over 40 industrial sites, including distilleries and their haulage fleets, creating a localized "hydrogen cluster."

Much smaller but the tidal invinity ITM power test project is planned to be rolled out to 20 sites and from there who knows.

In late 2025, the Ardersier facility is no longer just a "planned" site; it has evolved into a centerpiece of the Inverness and Cromarty Firth Green Freeport.

The selection of electrolyser technology for Ardersier is governed by its role as a "Gigawatt-scale" hub, specifically serving the Cerulean Winds floating offshore projects. 

1. The Electrolyser Selection: Technology Type

While a specific manufacturer (like ITM or Nel) hasn't been locked into a single "exclusive" contract for the entire 500-acre site, the Cerulean Winds consortium and Haventus (the port owners) have shifted toward PEM (Proton Exchange Membrane) technology for the initial phases.

• Why PEM? As we discussed with the Highland wind variability, PEM is the only technology that can handle the "spiky" power coming from floating offshore wind farms without needing a massive grid connection to stabilize it.

• The "Tier 1" Consortium: Cerulean Winds uses a "Delivery Consortium" model. Their partner for the electrical and process infrastructure is NOV (National Oilwell Varco). In 2025, NOV is working with sub-suppliers who specialize in containerized PEM stacks that can be easily "plugged in" as the wind farm grows. 

2. The Size in Megawatts (MW)

The scaling of Ardersier is being done in "blocks" to match the power coming from the offshore cables:

• Phase 1 (The Pilot): A 20 MW to 50 MW "demonstrator" unit is planned for 2026/27. This is designed to prove the "shore-to-ship" bunkering for the vessels servicing the Moray West and Moray East wind farms.

• Phase 2 (The Aspen Link): Once the 1 GW (1,000 MW) Aspen floating wind farm starts sending power via its direct cable (targeted for 2028-2029), the electrolyser capacity is expected to scale to 200 MW to 400 MW.

• Long-term Target: The "Green Freeport" designation allows for a total cumulative capacity of up to 1 GW (1,000 MW) of electrolysis across the Ardersier and Cromarty Firth sites by 2035.

The gas network is being tested and upgraded to carry H2 initially for blending with methane, but ultimately for transfer south and storage in caverns in Cheshire and Yorkshire. Kintore and Grangemouth. Literally huge amounts of Engineering work to happen up here.

Meanwhile Ardessier nigg and Inverness are all lined up for offshore floating wind. Ardessier has had a large chunk of change invested and the Chinese are lined up to invest £1.5B for floating turbines. Look at scotwind website. No doubt the Firth of Forth will be similar.

The main reason that regional pricing wasn’t adopted was the fear it would put off investment in onshore and offshore wind. Up north the locals are rightly unhappy at the number and location of new onshore wind farms, substations and transmission pylons. SPEN and SSE have committed about £30B each to upgrading the grid including pumped storage at Loch Ness; at least 3 schemes are moving forward.

If GE are incorporating the software in their MRI this has to increase turnover.

I do think below which was previously posted reflects a pivot point:

Thank you to BrainStorm Health for bringing awareness to the GBM community! https://lnkd.in/gMVy8xBF

There are at least three potential pieces of news on GAM that we are waiting on, Breakthrough Therapy designation which would be significant, passing of the PRV extension in the senate which seems likely and hopefully before Christmas with the cross party support and phase 2 funding. Would a major provide the funds or investor for a part of the PRV or are we looking at charitable support with some dilution.

While RWE and ITM Power have not officially confirmed the destination, these two projects are the strongest UK candidates because their capacity requirements and timelines align well with the reservation agreement.

Here is the analysis focused solely on the two UK sites:

🏴󠁧󠁢󠁷󠁬󠁳󠁿 1. Pembroke Green Hydrogen Plant (Wales)

The Pembroke project is the most mature and most likely initial recipient of the reserved capacity.

• RWE Project Capacity (Phase 1): Circa 100 MWe electrolyser.

• Suitability for ITM: This capacity requires 20 of the 5 MW NEPTUNE V units, making it a perfect fit for the reserved modular technology.

• Timeline Alignment:

• Planning: RWE has secured full planning approval for the project.

• Operation Target: Phase 1 is currently scheduled to be deployed by 2027.

• Call-off Window: This perfectly matches ITM's stated "call-offs by 2027" for the 150 MW reservation.

• Significance: Utilizing 100 MW of the reservation here would immediately convert a significant portion of the reservation into a firm order for a fully approved, high-priority project.

🏴󠁧󠁢󠁳󠁣󠁴󠁿 2. Grangemouth Green Hydrogen Production Facility (Scotland)

Grangemouth is a larger, strategic project that could utilize the remaining reserved capacity.

• RWE Project Capacity (Initial Phase): Up to 200 MWe electrolyser.

• Suitability for ITM: This project is large-scale and strategically important. If RWE decides to use ITM's modular technology for the entire 200 MW, it would require 40 of the 5 MW NEPTUNE V units.

• Timeline Alignment:

• Status: RWE is actively progressing toward a planning application (consultation phase completed) and has secured the grid connection.

• Operation Target: The project is anticipated to be operational by 2029.

50MW

🌊 H2opZee Electrolyser Requirements

300 – 500 MW of electrolyser capacity is required for this world-first offshore demonstration project. 

The technology must be:

1. High Capacity: Scaled for hundreds of megawatts, proving gigawatt-scale offshore production is viable.

2. Robust: Engineered to withstand the harsh, corrosive North Sea environment.

3. Flexible: Capable of handling the variable power input directly from offshore wind, optimizing system integration.

4. Compact: Designed for minimal footprint on an offshore platform.

The project's implementation phase requires defining a tender methodology to secure this specialized technology, aiming for operation before 2030.

Look up aquaventus and see who are members:

https://aquaventus.org/wer-wir-sind/mitglieder/

Not sure if it has been posted but Grangemouth looks like a 100MW scheme and this aligns with the 150MW call off reservation.

https://uk.rwe.com/project-proposals/grangemouth-green-hydrogen/

The first flickers of life and a new dawn. Let’s hope so…

Thanks Troublesome. Learnt something from this article.

https://www.statkraft.co.uk/newsroom/2023/a-route-to-market-for-green-hydrogen/

Nothing unexpected from an initial look and based on number and regulatory of raises. Going forward is key I e number of contracts won over the next year.