Poolbeg Pharma

Addressing cancer immunotherapy's biggest bottleneck

Good Morning Team.

Poolbeg Pharma was christened for the peninsula within Dublin Bay - made famous for its towering Poolbeg Chimneys, and the bright red Poolbeg Lighthouse, situated at the end of the 4km Great South Wall.

(I’m reasonably confident this is a giant model of a Dalek and the Irish are having a little joke at our expense).

The founders - Cathal Friel, Ian O’Connell, Carol Dalton and CEO Jeremy Skillington - are all Irish and Poolbeg has a special place in the hearts of their countrymen.

For those departing the country during the economic hardships of the 20th century, the lighthouse (which sits at the end of one of the longest seawalls in the world) and then the chimneys, which tower over the cityscape, were the very last glimpse of home fading over the horizon.

They were also the first thing an eagle-eyed child might glimpse on the return.

Indeed, when the country’s electricity supply board suggested demolishing the chimneys in 2014, a massive public outcry forced the state to protect them as vital monuments of Irish heritage.

Not because they are beautiful, but because they serve as essential landmarks of identity and resilience.

This is fitting, as the pharma company’s flagship assetis specifically designed to work in a pair with other therapies, knows what to target - and what needs to be left alone.

Let’s dive in.

Tl;dr

For those of you lacking time or an attention span, here’s the elevator pitch:

Poolbeg Pharma is attempting to solve one of the principal bottlenecks limiting wider adoption of modern cancer immunotherapies — Cytokine Release Syndrome.

Unlike companies developing the underlying cancer treatments themselves, Poolbeg is building a potentially platform-agnostic supportive-care therapy that could, in theory, be paired with multiple CAR-T and bispecific antibody products across numerous Pharma company manufacturers, rather than depending on the fate of a single oncology drug.

If POLB 001 successfully prevents CRS without reducing anti-tumour efficacy, the company could address a massively expanding market while becoming strategically relevant to much of the cancer immunotherapy ecosystem.

The investment case therefore rests less on developing a better cancer drug, and more on enabling existing breakthrough therapies to reach more patients, in more settings and with fewer complications.

This, in my view, enjoys an inherently higher chance of succeeding as a result.

However, as ever, all biotech plays are inherently risky - do your own research and consider your risk profile. Only you live with your profits and losses.

Now, for those of you with time on your hands:

The Setup: A Breakthrough Cancer Treatment With a Dangerous Side Effect

Over the last decade, cancer immunotherapy has gone through a revolution.

Bispecific antibodies (BsAbs) and CAR T-cell therapies have transformed outcomes for patients with blood cancers including multiple myeloma and lymphoma. Poolbeg’s own investor materials illustrate this - a multiple myeloma patient diagnosed in 2003 had a 5-year survival rate of roughly 30–35% on chemotherapy and stem cell transplant; a patient diagnosed in 2026, with access to CAR T therapy and bispecific antibodies, has an estimated 5-year survival rate of over 80%.

This is, objectively, incredible progress.

But this new generation of therapy comes with a serious catch.

Cytokine Release Syndrome (CRS).

When these immunotherapies activate the immune system, they can trigger a systemic inflammatory cascade — fever, hypotension, hypoxia, and in severe cases, multi-organ failure and death.

According to data Poolbeg cites from the summary product characteristics of leading approved CAR-T and bispecific products (Yescarta, Tecartus, Abecma, Kymriah, Carvykti, Breyanzi, Elrexfio, Columvi, Epkinly, Tecvayli and Talvey), CRS affects more than 70% of patients receiving these treatments.

The practical consequence is that these breakthrough therapies are currently restricted almost entirely to specialist cancer centres capable of managing CRS, dosing has to be withheld until CRS resolves (delaying effective treatment), and patients who experience high-grade CRS may have to permanently discontinue what could be a life-saving therapy.

There is currently no approved preventative therapy for CRS — only reactive treatments like tocilizumab (an IV infusion) once symptoms have already begun.

This is the gap Poolbeg is trying to fill with its lead asset:

POLB 001, an Oral p38 MAPK Inhibitor

POLB 001 is a small-molecule, orally-delivered inhibitor of p38 MAPK (mitogen-activated protein kinase) — a pathway the company describes as a ‘gatekeeper’ to inflammatory cytokine production.

The pitch is surprisingly basic - by inhibiting this single upstream pathway, POLB 001 can blunt the excessive cytokine storm that drives CRS, without ablating the underlying immune response the cancer therapy needs in order to actually kill tumour cells.

That last point is critical and is where a lot of the bull case’s scientific credibility rests.

It’s easy to suppress inflammation broadly (steroids do this). It’s much harder to do it selectively enough that you don’t also blunt the anti-cancer effect of the drug you’re trying to make safer.

Poolbeg has generated data across three levels — human challenge trial, in vivo cancer models, and now in vitro tumour-killing assays — that all point toward this selectivity holding up.

Why p38 MAPK May Be Succeeding Where Earlier Programmes Failed

Experienced biotech investors will likely recognise that p38 MAPK is not a novel drug target — it’s actually a target with a fairly checkered history.

Over the past two decades, numerous p38 inhibitors have been investigated for chronic inflammatory diseases including rheumatoid arthritis, COPD and inflammatory bowel disease, and none ultimately reached the market.

Those earlier programmes were generally undone by limited efficacy in chronic disease settings, long-term safety concerns with continuous dosing, and the tendency of inflammatory pathways to find workarounds around p38 inhibition over extended treatment time.

POLB 001’s advantage is that it’s addressing a fundamentally different clinical problem than those earlier failures.

Rather than requiring years of continuous dosing to manage a chronic condition, CRS develops over a short, predictable window immediately following CAR-T or bispecific antibody administration.

POLB 001’s dosing regimen is designed around that window specifically — a twice-daily oral dose confined to the acute high-risk period, not indefinite daily use.

That distinction doesn’t guarantee success, but it is a good answer to the most obvious objection you might raise on hearing ‘p38 inhibitor’: hasn’t this been tried and failed before?

The Oral, Preventative Angle

The oral formulation carries practical advantages that go beyond convenience.

Current CRS management relies almost entirely on intravenous rescue therapies administered only after symptoms have already developed. An oral preventative treatment, by contrast, could be taken before the cytokine cascade even begins.

If effective, that timing shift could simplify treatment logistics, reduce hospital resource utilisation, and support the broader decentralisation of advanced cancer therapies out of specialist infusion centres and into routine oncology settings — the shift multiple KOLs quoted in Poolbeg’s own materials (Professor Martin Kaiser of the Royal Marsden among them) describe as the real prize here.

Data supporting the thesis to date includes:

1. Phase 1b LPS Human Challenge Trial (published, peer-reviewed)

This was a randomised, double-blind, placebo-controlled trial in healthy volunteers, using bacterial lipopolysaccharide (LPS) to trigger an inflammatory response, testing POLB 001 against placebo across multiple doses (30mg, 70mg, 150mg).

The results, later published in the peer-reviewed journal Frontiers in Immunology (January 2026), showed:

• IL-6 reduced by 57.4%–63.5% (70mg/150mg doses, p=0.0002)

• IL-8 reduced by 80.7%–76.7% (p<0.0001)

• TNF-α reduced by 73.5%–56.2% (p=0.0003)

• CRP reduced by 33.1%–33.3%

• Suppressed heart rate rise following LPS challenge (p<0.0001)

• Clear, potent, dose-dependent inhibition of phosphorylated p38 MAPK in circulating monocytes — direct confirmation of target engagement

• No serious adverse events, no discontinuations, all adverse events mild, across 97 subjects dosed in Phase 1 studies

This is an objectively clean safety and pharmacology dataset, and its publication in a peer-reviewed journal (rather than just a company press release) adds a layer of external, independent scrutiny.

2. Preclinical in vivo CRS model

Separately, Poolbeg has released in vivo data (in a humanised, tumour-bearing mouse model of bispecific-antibody-induced CRS) showing POLB 001 significantly decreased peak serum levels of TNF, IFNγ and IL-6 — the same key CRS cytokines flagged in the human challenge data — reinforcing the translational story from healthy volunteers into an actual cancer/immunotherapy setting.

3. Preserved tumour-killing activity — the critical de-risking data point

New preclinical data presented at the European Hematology Association (EHA) Congress in Stockholm (June 2026) showed that in an in vitro model using primary human blood samples, a tumour cell line, and two commercially available bispecific antibodies, POLB 001 did not impair bispecific-antibody-induced tumour cell killing while still reducing CRS-associated cytokines.

This is arguably the single most important scientific checkpoint for this whole programme. Any pharmaceutical company evaluating a supportive-care add-on to their oncology franchise will ask one obvious question first: does this drug compromise the effectiveness of our therapy?

If the answer is yes, commercial conversations cease.

Management has indicated that preclinical work, somewhat of a gate to Johnson & Johnson’s involvement, specifically addressed this question, and the early answer appears to be no — POLB 001 does not appear to interfere with the underlying immunotherapy’s tumour-killing activity.

That’s not proof of an imminent deal, but again, it appears to remove another of the more serious objections a potential partner’s due diligence team would raise.

4. A second indication emerging: AML

Also at EHA, University of Manchester researchers presented data suggesting POLB 001 may improve outcomes for elderly Acute Myeloid Leukaemia (AML) patients when combined with azacitidine, a first-line AML treatment.

This in vivo work in aged mouse models is very early-stage, but it signals that POLB 001’s utility may not be confined to CRS prevention alone — indeed, the company sees life-cycle potential in broader inflammation-driven oncology settings, including ‘severe influenza’ as a longer-term secondary indication already covered by existing patents.

TOPICAL, and Why It’s Designed to Read Out Fast

Poolbeg’s clinical validation strategy centres on the TOPICAL trial (Trial of Prevention of ImmunoCytokine Adverse events in Myeloma) — a first-in-patient, single-arm, open-label clinical study.

Design specifics:

• Circa 30 relapsed/refractory multiple myeloma patients

• Receiving the approved bispecific antibody teclistamab, supplied by Johnson & Johnson at no cost to Poolbeg — a solid cost saving and more importantly an implicit signal of J&J’s interest in the space (endorsement might be too strong a word, but it’s close)

• Twice-daily oral POLB 001 dosing, timed around the ‘high-risk period’ for CRS onset (roughly the first two weeks around initial BsAb dosing)

• Primary endpoints - incidence and severity of CRS, safety/pharmacokinetics, and CRS management/tocilizumab usage

Why the speed matters: unlike most oncology efficacy trials — which can take years to show survival or progression benefits — CRS is an acute condition that manifests within days to weeks of starting a bispecific antibody.

That means TOPICAL is structured to generate a rapid readout, rather than requiring the years-long follow-up typical of oncology trials.

What success looks like: Because TOPICAL is a single-arm study without a placebo control, investors shouldn’t expect conventional head-to-head efficacy statistics from the interim data.

Instead, outcomes will most likely be interpreted against well-characterised historical CRS incidence and severity rates already reported in the clinical literature and product labelling for teclistamab (circa 72% historically) and comparable bispecific antibodies.

A reasonable (or yes, let’s hope gigantic) reduction in CRS incidence, severity or need for rescue therapy (like tocilizumab) versus those historical benchmarks would represent an important proof-of-concept — though larger, controlled studies would still be required before any registration pathway.

However, I’d argue at this stage J&J or another major would be prepared to dig out the chequebook for some funding.

Operational momentum (as reported by the company through 2026):

• MHRA Clinical Trial Authorisation granted (April 2026)

• Six NHS trial sites now active/onboarding: The Christie, The Royal Marsden, University College London Hospitals, University Hospitals Birmingham, NHS Lothian, and Royal Stoke University Hospital

• Trial run by Accelerating Clinical Trials (ACT), a specialist blood cancer CRO, with Dr Emma Searle (Consultant Haematologist, The Christie) as Chief Investigator

• First patient dosed (announced 13 July 2026), with UCLH activated as the second site and additional sites expected to open imminently

• Company describes ‘unsolicited enquiries from investigators’ wanting to join the study — clinical enthusiasm, which is unsurprising given the lack of alternatives on-market

• Interim data guided for late summer 2026 — the single biggest near-term catalyst for the stock

(I’ll be honest here - I suspect it’ll be September because unless forced, nobody wants to release meganews in August).

Market Opportunity: Independently Sized at Multi-Billion-Dollar Peak Sales

Poolbeg has leaned heavily on third-party market research to validate its potential commercial scale, rather than relying purely on internal projections. This helps, a lot.

• Original 2024 research pegged the opportunity in multiple myeloma, high-grade lymphoma and acute lymphoblastic leukaemia alone at >$1 billion, later revised upward to >$10 billion as scope expanded across the broader universe of CRS-inducing immunotherapies.

• In April 2026, independent US payer research conducted by Acumetis Global, which engaged payers covering roughly 75 million lives across commercial insurance, Medicare and Medicaid, confirmed a multi-billion-dollar peak US sales potential, and specifically found a ‘willingness to pay at commercially meaningful price points’ driven by the potential to cut hospitalisation costs and decentralise care away from specialist centres.

• Supporting context on scale - diagnosed DLBCL and multiple myeloma patients alone are projected to reach 500,000 patients in the US and EU5 between 2023–2030 (other indications not even included). Average CAR-T therapy costs $402,500 (2025 figure) and bispecific antibody therapy $250,000 per course (2023 figures); the cost of treating a single patient with Grade 3 CRS can exceed $70,000. As a comparator for what a well-targeted supportive-care drug can achieve commercially, Poolbeg points to Neulasta (a neutropenia drug), which achieved peak sales of $5.8 billion at roughly $18,000 per treatment cycle.

• Separately, the broader CAR-T/BsAb market itself is forecast to grow to $100–140 billion by 2030, meaning POLB 001’s addressable market scales with the very immunotherapy boom it’s designed to support.

Why This Could Become a Platform Opportunity, Not a Single-Product Bet

As noted above, POLB 001 doesn’t compete with the underlying cancer therapy — it complements it.

Every new bispecific antibody or CAR-T therapy approved for a CRS-prone indication potentially expands the addressable market for a preventative CRS treatment, rather than shrinking it through competition.

Instead of Poolbeg’s fortunes being tied to the commercial success of one particular oncology drug from one particular manufacturer, POLB 001 could theoretically be paired across numerous bispecific and CAR-T products from multiple companies simultaneously. That reframes this less as a single-product bet and more as a platform opportunity riding alongside the entire immunotherapy category’s growth.

Competitive Landscape

Despite the rapid expansion of CAR-T and bispecific antibody therapies, the competitive landscape for preventative CRS treatment specifically remains relatively sparse.

Current standard of care relies primarily on supportive care and reactive administration of agents like tocilizumab once CRS has already developed. While a number of companies are working to optimise their underlying immunotherapies to reduce inherent toxicity, relatively few appear to be developing standalone, oral, prophylactic therapies designed specifically to prevent CRS before it starts.

This positioning could prove strategically valuable - a preventative therapy that isn’t tied to any single manufacturer’s oncology product has the potential to integrate across multiple treatment platforms, letting the commercial opportunity expand alongside the broader immunotherapy market rather than compete for share within it.

And the majors WANT this solution to be found.

Manufacturing Simplicity as a Margin Argument

It’s also worth noting that POLB 001 is a conventional small-molecule oral therapy with confirmed good bioavailability – ideal for this indication.

Manufacturing, storage and distribution should, in theory (yes, I know!), be much simpler and cheaper than the biologic immunotherapies it’s designed to support. Pricing and reimbursement remain unknown at this stage, but lower manufacturing complexity is obviously a good starting point for eventual commercial margins if the product reaches market.

The logic here is structural, not just financial - CRS isn’t a side issue to this market’s growth — it is, per the company’s own framing (echoed by KOLs quoted in these releases, including Professor Gareth Morgan of NYU Langone and Professor Martin Kaiser of the Royal Marsden), the actual bottleneck constraining how widely these therapies can be deployed.

An effective, oral, preventative CRS therapy doesn’t just capture a slice of an existing market — it could be what unlocks decentralisation of the entire treatment paradigm, moving bispecific/CAR-T administration out of specialist centres of excellence and into community hospitals or even home settings.

Why Interim Data Matters Regardless of the Headline Number

The summer 2026 TOPICAL interim readout carries weight beyond a simple pass/fail framing.

Even relatively modest evidence that POLB 001 can reduce CRS incidence or severity while preserving anti-tumour activity in actual patients — as opposed to healthy volunteers or animal models — would materially de-risk the entire programme.

It would demonstrate that the encouraging translational story built up across the LPS challenge trial, the preclinical CRS models and the in vitro tumour-killing assays can actually carry through into the clinical setting it was designed for.

For a company that is explicitly partnering-focused rather than planning to commercialise alone, that reduction in scientific uncertainty will in my view matter to a prospective licensing partner at least as much as the specific headline efficacy numbers.

The majors deal in the billions - they will have no problem chucking some cash at this if the result is even half-decent.

This is key - the results don’t need to be incredible. They just have to be something. There’s nothing else.

Regulatory & IP Position: Global, Actively Expanding Moat

This is one of the more underappreciated parts of the investment case — Poolbeg has been very active on the IP front, and it isn’t just a UK/US story:

• FDA Orphan Drug Designation granted (May 2025) for POLB 001 as a preventative therapy for T-cell engager bispecific antibody-induced CRS — carrying potential 7-year US market exclusivity, PDUFA fee waivers, and tax credit eligibility for qualifying trials.

• Positive FDA pre-IND meeting (May 2026): the FDA’s feedback was broadly aligned with Poolbeg’s proposed Phase 3 development pathway, including agreement on the proposed primary endpoint and what a drug label looks like — a de-risking event for any future partner assessing regulatory pathway certainty.

• A rapidly-expanding cancer-immunotherapy-CRS-specific patent family, with national grants secured in quick succession through 2026: Australia (March 2026), Canada (May 2026), European Patent Office (decision to grant, June 2026), and South Africa (June 2026) — the European grant in particular being described by the company as ‘the most commercially significant grant to date’ in this family.

• Separately, an entirely distinct patent family covers POLB 001 for hypercytokinemia/severe influenza, with grants already secured in the US, EU, South Korea and Hong Kong, and coverage running through to December 2038.

• Management explicitly frames potential patent coverage as extending out to 2044 when accounting for the newer CRS-specific family and future formulation/clinical-finding filings. Which is more than enough.

For a company of Poolbeg’s size, this is a dense and geographically diversified IP estate — arguably disproportionate to its market cap, and a factor that directly feeds into partnering leverage.

The RISE Programme - Independent Academic and Industry Validation

In December 2025, Poolbeg announced it would be the lead business partner (alongside Johnson & Johnson) in the RISE programme (Reducing Immune Stress from Excess cytokine release in advanced therapies) — a research initiative led by the University of Manchester and The Christie NHS Foundation Trust, backed by a £3.4 million Medical Research Council Prosperity Partnership grant (part of a wider £9 million public-sector MRC investment).

The significance here is that this isn’t Poolbeg funding its own validation.

It’s a UK government research council, a major academic cancer centre, and a top-five global pharmaceutical company all co-investing in a research infrastructure where the TOPICAL trial sits as a ‘central element.’

It both broadens the data being generated on POLB 001 beyond what the company alone is funding, and signals third-party institutional confidence in the underlying science — all without touching Poolbeg’s own cash runway.

Why Big Pharma Might Actually Want This

Poolbeg is explicitly structured as a partnering-focused business model — it doesn’t intend on any level to commercialise POLB 001 alone. The case for a partnering exit/deal rests on a few converging factors:

1. The pharma patent cliff. Citing Evaluate (2026) data, the company notes that between 2025 and 2030, $300 billion in annual prescription drug revenue will lose patent protection — creating strong incentive for large pharma to acquire differentiated late-stage or de-risked clinical assets.

2. A growing roster of CRS-inducing therapies already in the clinic, meaning the addressable market for a CRS-prevention adjunct grows every time a new bispecific or CAR-T product is approved — POLB 001 isn’t tied to a single competitor’s product, and demand for a solution is growing exponentially.

3. Active, ongoing partnering conversations, per the company, with both mid-sized and Big Pharma companies, plus cancer supportive-care and immunotherapy specialists — alongside a busy 2026 conference circuit (JPM Week, BIO Europe, LSX World Congress, British Society for Haematology Annual Scientific Meeting, EHA 2026, and BIO Convention) where management has been actively engaging prospective partners. There have also been some indications that a data room has been opened for prospective partners to conduct due diligence ahead of interim data.

4. J&J’s in-kind involvement (free teclistamab supply for the trial, plus RISE programme participation, plus the preclinical collaboration on tumour-killing preservation noted above) is arguably the single most tangible signal that a major pharma player is already engaged with the asset in some capacity, even if it is short of a formal deal.

5. Direct strategic alignment with oncology manufacturers’ own incentives. Manufacturers of bispecific antibodies and CAR-T therapies have a clear commercial motive to reduce the treatment-limiting toxicities that restrict patient access, delay dosing, or increase hospital costs for their own products. A successful preventative CRS therapy improves the value of an existing oncology franchise without requiring the manufacturer to redesign or re-engineer their underlying cancer treatment. That’s a far easier ‘YES’ for a potential partner than being asked to adopt a wholly new mechanism of action into their core drug.

Management has been explicit that the intent is to use TOPICAL’s interim data as the trigger to accelerate and convert these partnering conversations into an actual deal.

Could POLB 001 Become Standard Practice?

One of the more ambitious, longer-horizon parts of the bull case is the idea that POLB 001 doesn’t need to replace anything to succeed — it just needs to become an easy, low-friction addition to existing treatment protocols.

Much as supportive-care medicines like anti-emetics, growth factors, and infection prophylaxis have become routine, unremarkable components of standard oncology practice over the past few decades, it does seem possible that if clinicians become convinced prophylactic POLB 001 reduces CRS without compromising anti-cancer efficacy, it could eventually occupy a similarly automatic position alongside high-risk immunotherapy administration.

That’s a much larger and more durable outcome than a one-off licensing payout — it’s closer to a recurring, embedded revenue stream tied to the entire immunotherapy category’s continued growth.

But it’s also the blue sky and should be viewed as such at this stage.

Second Pillar: The Oral GLP-1 Programme

While POLB 001 is clearly the flagship, Poolbeg is also developing an oral, encapsulated GLP-1 receptor agonist for obesity — riding the well-documented boom in GLP-1 drug demand ($20.2 billion in 2025 obesity/diabetes deal-making per JP Morgan; GLP-1R agonist market projected at $150 billion by 2031 per The Economist).

The differentiation here is delivery, not the molecule itself - Poolbeg is using a Generally Recognised as Safe (GRAS) oral encapsulation technology, developed with AnaBio Technologies (an FDA-accredited, 2,000m² manufacturing facility in Ireland), employing a pH-sensitive release mechanism to target a specific area of the gut where GLP-1 receptors reside.

The pitch is that this could solve the well-known bioavailability problem that has made oral delivery of peptide-based GLP-1 drugs difficult, offering a more ‘patient-friendly’ alternative to injectables.

• A proof-of-concept trial (up to 20 obese subjects) is being led by Professor Carel le Roux at the University of Ulster — the chap is an independently well-recognised name in metabolic medicine.

• The trial had been expected in H1 2026 but has slipped to this half due to revised manufacturing lead times.

• Endpoints are safety, tolerability and pharmacokinetics — a lower bar than efficacy, but designed, per management, to ‘complete quickly following first subject dosing,’ giving a second rapid-turnaround catalyst this year.

This program functions as a call option within the stock — not the core investment thesis, but a second, largely separate value driver with its own patent estate (protection potentially running to 2044–2045) and its own partnering optionality.

And they want results fast - for me, the idea is any indication of success and they’ll devote more capital. But if not, then the actual cash spend is limited.

Success here would be incredible though. Speculation only, but think about what an oral weight loss drug could command in terms of ease of use, increased TAM and value.

The core point I think the company might have struggled to get across is that other oral alternatives suffer from poor drug absorption - they lose over 99% of their active ingredients to the HCL acid and enzymes in your stomach.

Instead of altering the drug molecule itself, Poolbeg is wrapping the delicate GLP-1 peptide inside a protective microencapsulation shield.

This ‘intelligent’ coating features a pH-sensitive release mechanism that keeps the drug sealed through your acidic stomach and only opens once it reaches the optimal absorption site in the small intestine.

By significantly increasing the amount of medication that successfully enters the bloodstream, the approach aims to make oral dosing far more efficient and also eliminate strict pre-food fasting rules.

Basically, it’s just better.

Management & Board: A Team That’s Done This Before

A recurring theme is management’s pedigree, specifically their prior involvement in Amryt Pharma, a rare-disease company that was successfully built and ultimately sold (Amryt was acquired by Chiesi Farmaceutici in 2023 in a deal reportedly worth over $1 billion, with additional milestone payments).

• Cathal Friel (Executive Chairman) — co-founder of hVIVO (formerly Open Orphan) and Amryt Pharma, also linked to Raglan Capital.

• Jeremy Skillington, PhD (CEO) — prior roles at Inflazome, Genentech, and Ethris.

• Ian O’Connell (CFO) — also ex-hVIVO/Amryt, and Deloitte.

• Liam Tremble (Principal Scientist) — ex-hVIVO, with academic ties to UCC and Trinity College Dublin.

The non-executive board is similarly well-credentialed: Professor Luke O’Neill (co-founder of Inflazome, sold to Roche in 2020 for €380 million plus milestones where Skillington was instrumental in the transaction), Eddie Gibson (market access expert, ex-Bristol Myers Squibb/AVEO Oncology), and Professor Brendan Buckley (former CMO at ICON plc, former committee member for Orphan Medicinal Products and the EMA’s Scientific Advisory Group for Diabetes and Endocrinology).

In March 2026, the Scientific Advisory Board was further strengthened with the addition of Dr Adrian Kilcoyne (CMO at Cellectis, formerly CMO at Celularity and Humanigen, with senior R&D roles at AstraZeneca, Celgene, Sanofi, Roche and Eli Lilly), bringing direct expertise in T-cell therapies and CRS specifically.

On insider ownership, Cathal Friel — already the company’s largest shareholder — personally subscribed for £250,000 of the July 2026 placing, and commentary following that raise has put his total personal investment in Poolbeg at roughly £1.5 million over time.

That’s a tangible financial commitment that demonstrates skin in the game, particularly given Friel has vocal in his confidence that the TOPICAL trial would succeed.

There’s also a qualitative signal worth flagging from recent management commentary - the tone has clearly shifted from executives explaining and defending the underlying science to discussing healthcare economics, reimbursement dynamics, hospital capacity, patient pathways and the mechanics of pharmaceutical partnering.

That’s not evidence in itself — confidence is not the same thing as clinical data — but a management team increasingly talking like it’s preparing to commercialise, rather than still trying to prove a concept, is at minimum a shift worth thinking about as this story develops toward its interim data catalyst.

HOOKIPA: Worth Understanding, Even Though It Fell Apart

In January 2025, Poolbeg entered non-binding discussions for an all-share combination with HOOKIPA Pharma Inc. (Nasdaq: HOOK), which would have created a Nasdaq-listed combined entity, with Poolbeg shareholders initially set to hold circa 55% (pre-fundraise dilution) of the combined group.

This deal would also have brought Gilead-partnered programmes into the mix, alongside a concurrent $30 million fundraise.

Ultimately, on 20 February 2025, HOOKIPA formally announced it did not intend to make an offer, and the deal was terminated. Friel’s comment at the time was blunt: Poolbeg was ‘surprised and disappointed’ but remained focused on its own in-house programmes.

Yes it fell apart.

But.

It demonstrates that Poolbeg’s asset base has attracted serious M&A interest from a Nasdaq-listed peer before, and at a much earlier stage.

Financials

1. Cash balance: £7.7 million as at 31 December 2025 (down from £10 million at 30 June 2025), following an oversubscribed and upsized fundraise of £4.865 million gross in June 2025. The company implemented ‘selective headcount reductions’ in 2025 to align resourcing with its near-term clinical priorities.

2. July 2026 placing: Poolbeg raised a further £3.5 million (before expenses) via a placing of circa 58 million new shares at 6p per share — a 16% discount to the prior close of 7.15p. As noted above, Executive Chair Cathal Friel personally subscribed for £250,000 of this raise.

3. This new capital, combined with existing resources, is guided to extend the cash runway into Q2 2028 — comfortably funding both the TOPICAL trial and the Oral GLP-1 proof-of-concept trial through to completion. There’s a strategic argument here beyond simply ‘more cash good’ - licensing negotiations rarely favour a company approaching the end of its runway, since a weak balance sheet gives a prospective partner leverage and can force management to accept worse terms simply because time is running out. By securing funding into 2028 ahead of the interim data readout, Poolbeg has bought itself negotiating time — time to let the data mature, time to assess partnering offers properly, and time to negotiate without an imminent funding cliff forcing its hand. Whether that produces a materially better eventual deal is unknowable, but the sequencing (raise now, ahead of the catalyst, rather than scrambling for cash after as I’ve seen others do to their detriment) is at least logically sound.

Catalyst Calendar

It’s worth just showing you a snapshot of what’s being achieved, as while there has been some delay, there has also been strong corporate progress:

• MHRA Clinical Trial Authorisation granted for TOPICAL

• FDA Orphan Drug Designation secured

• Positive FDA pre-IND meeting outcome

• Peer-reviewed LPS challenge data published in Frontiers in Immunology

• Patents granted: Australia, Canada, EU (decision to grant), South Africa, South Korea, Hong Kong, US

• EHA 2026 poster presentations (CRS prevention data + AML preclinical data)

• First patient dosed in TOPICAL trial

• Second site (UCLH) activated

• £3.5 million placing closed, cash runway extended to Q2 2028

Underway:

• Additional TOPICAL site activations

• Continued patient recruitment across active sites

Guided / upcoming:

• TOPICAL interim data — expected late summer 2026 (the central near-term catalyst)

• Oral GLP-1 proof-of-concept trial starts — expected H2 2026

The Bottom Line

Poolbeg Pharma is a small, thinly-capitalised biotech betting its future on a single, well-characterised molecule addressing a real and clearly-documented clinical gap.

There is currently no approved way to prevent CRS in patients receiving some of oncology’s most important new medicines.

That’s a fact.

The company has built a global and actively-expanding patent estate around that molecule, secured free drug supply and site access from a top-five pharmaceutical company for its pivotal trial, published peer-reviewed data supporting its mechanism, generated early evidence that the drug doesn’t blunt the very immunotherapy it’s meant to protect patients from, received supportive FDA regulatory feedback, and is now in the final stretch before a trial designed specifically to read out fast rather than over years.

Management has previously built and sold a comparable rare-disease biotech, the Executive Chair has backed that conviction with roughly £1.5 million of his own money, and the company has just extended its cash runway to mid-2028 — buying time to negotiate from a position of relative strength rather than desperation.

The next few months — interim TOPICAL data expected in late summer 2026 — represent the clearest test of whether this thesis converts from a well-constructed narrative into a company that can either land a partnering deal or generate enough clinical proof to be valued very differently than its current £44 million market cap suggests.

We shall see soon enough.