Zelluna: killer cells tackling the solid cancer bottleneck

To understand Zellunas current trajectory, one must look back to a defining moment in March 2025. In a strategic maneuver to accelerate development, the private biotech Zelluna Immunotherapy AS combined with the listed entity Ultimovacs ASA.

The backdrop was dramatic. Following a series of clinical setbacks in 2024 where the legacy vaccine programs faced significant challenges, Ultimovacs needed a new scientific heart to rise from the ashes. Zelluna provided the beat to drive it. In doing so, Zelluna became the first cell therapy company ever to list on the Oslo Stock Exchange.

This transformation signalled a definitive break from the past. By phasing out the legacy vaccine operations to become a "pure-play" TCR-NK company, Zelluna has effectively replaced the engine of the organization. The move was driven by the ambition to access public capital markets and secure the financial flexibility needed to bring a potential first-in-class solid tumor therapy to patients globally.

Overcoming industry hurdles

The core of this new public entity is a technology designed to tackle one of the most critical limitations in modern immuno-oncology. Zelluna distinguishes itself by pioneering a platform that combines the specific targeting capabilities of T-cell receptors (TCRs) with the innate killing mechanism of Natural Killer (NK) cells.

Current autologous therapies face a logistical bottleneck: they are slow, expensive, and require complex manufacturing for each individual patient. Furthermore, they often struggle with the biological challenge of penetrating solid tumors. Zelluna’s allogeneic ("off-the-shelf") TCR-NK approach addresses both hurdles, aiming to provide a scalable, cost-effective treatment that is ready when the patient needs it.

Green light for UK clinical strategy

With the corporate structure and technology in place, the company is executing on its clinical roadmap. A central highlight of the recent operational update is the regulatory progress in the United Kingdom. In October 2025, Zelluna received positive scientific advice from the Medicines and Healthcare products Regulatory Agency (MHRA).

This regulatory alignment covers critical aspects of the preclinical data, manufacturing processes, and clinical design for the lead candidate ZI-MA4-1. It paves the way for a Clinical Trial Application (CTA) submission later this year. To execute this phase, Zelluna has engaged high-profile expertise; Professor Fiona Thistlethwaite at The Christie in Manchester is proposed as Chief Investigator, with the trial design and strategy also shaped in collaboration with Dr. Andrew Furness at The Royal Marsden in London.

Transitioning from lab to GMP manufacturing

Parallel to the regulatory work, operational preparations have accelerated. During the summer of 2025, Zelluna initiated GMP (Good Manufacturing Practice) manufacturing of the clinical batch for the phase I trial in partnership with Catalent, a global leader in cell therapy manufacturing.

This collaboration is a pivotal de-risking step. It signifies that Zelluna has successfully translated its research protocols into a locked-down, scalable process capable of delivering clinical-grade material – a critical verification of the "off-the-shelf" promise.

Pipeline expansion and financial runway

While the immediate focus remains on ZI-MA4-1, Zelluna is actively broadening its horizon. In the third quarter, the company acquired a portfolio of TCRs targeting KKLC1 from the German TCR-specialist Medigene. This clinically validated cancer antigen complements the lead program and reduces dependency on a single target.

Financially, the company stands on solid ground. Supported by a private placement executed on November 3, 2025, Zelluna now projects a cash runway extending into the first quarter of 2027.

On December 9, the Board cancelled a planned repair offering. With shares trading below the subscription price, the company concluded that shareholders can instead purchase shares directly on the open market, allowing Zelluna to avoid unnecessary administrative costs.

Q&A with CEO Namir Hassan

To gain deeper insight into Zelluna’s path forward, BioStock spoke with CEO Namir Hassan.

Investors followed the "old" company for years. How does the investment case for the new, pure-play Zelluna fundamentally differ from the legacy operations?

– The Zelluna of today is an entirely different company from the legacy organisation. The outcome of the merger for the ”old” company resulted in a new technology, a new strategy, and a new leadership team - with deep expertise in immunotherapies – as well as a wholly differentiated therapeutic approach. Our investment thesis is built around delivering first-in-class, off-the-shelf TCR-NK cell therapies for solid tumours, an area with significant unmet need and very limited competition. Our lead programme, ZI-MA4-1, is on the cusp of clinical entry and is set to become the world’s first MAGE-A4-targeting TCR-NK therapy, applicable across multiple solid cancers. Importantly, the entire TCR-NK platform is protected by a landmark, granted patent providing dominant intellectual property coverage across the entire TCR-NK field, a major strategic advantage as the platform advances.

- Another important distinction from the legacy business is that Zelluna operates in a field - cell therapy - that is clinically validated. There are nine approved cell therapies globally, demonstrating unequivocally that cell therapies can work. These approvals are primarily in liquid cancers; we are focused on solid tumors, which account for ~90% of the global cancer burden.

– Since the merger, we have delivered substantial progress:

• Successfully completed the integration and transitioned to a publicly listed, pure-play TCR-NK company
• Expanded our pipeline with Medigene's KKLC1-targeting TCRs
• Locked the scalable, GMP-ready manufacturing process for ZI-MA4-1, applicable across the entire TCR-NK platform
• Completed the full preclinical data package for ZI-MA4-1
• Produced the first clinical GMP batch, enabling clinical start
• Engaged leading UK investigators – Professor Fiona Thistlethwaite (The Christie) as Chief Investigator and Dr Andrew Furness (Royal Marsden) – to execute the first-in-human trial
• Received positive feedback from the UK MHRA on preclinical, CMC, clinical design and patient screening
• Strengthened our financial position with a NOK 58 million raise, extending runway into 2027 and enabling initial clinical data

- Zelluna is a focused, off-the-shelf cell therapy company with a validated strategy, a clinical-ready asset, a scalable platform, and strong IP protection. This comes at a time when major industry transactions are increasingly validating the shift towards scalable, off-the-shelf cell therapies. Over the past year, six high-profile deals have been executed by companies such as Roche, AstraZeneca, Kite, AbbVie and Bristol Myers Squibb, many based on early, limited clinical data and largely focused on liquid tumors. In contrast, Zelluna's platform is purpose-built for solid cancers, which represent the vast majority of the global cancer burden

This represents a fundamentally stronger and more compelling investment case than anything that preceded itCurrent cell therapies often struggle to treat solid tumors effectively. How does combining TCRs with NK cells specifically unlock the ability to attack these hard-to-reach cancers?

– Solid tumors are heterogeneous and demand a therapy that can do two things at once: precisely target tumor cells, and kill them through multiple recognition mechanisms to reduce the chance of tumor escape. TCR-NKs are uniquely positioned to deliver both.

• The TCR provides high-precision, clinically validated tumor targeting – something antibodies and CARs often cannot achieve.
• The NK cell adds potent innate cytotoxicity and multi-signal tumor recognition. NK cells detect stress signals, missing-self, and other tumor features – giving them multiple ways to kill cancer cells even when antigen expression fluctuates. NKs also have a well-established favorable safety profile and are suitable for outpatient treatment

– By combining these strengths, ZI-MA4-1 becomes a precisely targeted yet multi-sensing cancer-killing cell, designed to overcome the biological barriers that limit many current approaches. Importantly, it avoids many of the safety challenges associated with other cell therapies.

– This is why we believe TCR-NKs could unlock solid tumors in ways other modalities have not, while offering a scalable, off-the-shelf product that can reach patients quickly and broadly.

You emphasize the "off-the-shelf" aspect of your platform. Why do you believe the industry must shift away from patient-specific (autologous) treatments to succeed long-term?

- Autologous therapies have demonstrated what cell therapy can achieve, but they are fundamentally limited in ways that prevent broad and sustainable impact. They are:

• Slow and operationally complex, with manufacturing that takes weeks for each individual patient
• Highly variable, as product quality depends on the patient's own immune system
• Difficult and costly to scale, restricting access to a small number of specialized centres

– For solid tumors – where patients often decline rapidly – ​​these constraints become critical. Many patients simply cannot wait.

– Our off-the-shelf TCR-NK platform is built to overcome these barriers. It offers:

• Immediate availability, so patients can be treated when they need it
• Use of healthy donor cells ensuring consistent, reproducible quality, independent of disease stage or prior treatments
• True scalability, enabling broad global access at a cost structure autologous systems cannot match

– If cell therapies are to reach large patient populations and become a mainstream modality in oncology, the field must move beyond patient-specific manufacturing. We believe off-the-shelf products will define the next decade of immuno-oncology – and TCR-NKs have the potential to lead that transition.

Regarding your pipeline expansion and the recent KKLC1 acquisition from Medigene – what is the strategic rationale behind broadening the portfolio beyond your lead candidate?

– The KKLC1 acquisition strengthens our strategy on multiple levels:

1. Target diversification:

- It broadens our reach across a wider range of solid tumors, increasing the number of patients we can ultimately treat.

2. Highly validated tumor biology:

– KKLC1 is a well-characterised, validated cancer antigen with strong and selective expression in several difficult-to-treat solid tumours. This makes it an ideal fit for our TCR-NK approach.

3. Platform scalability and credibility:

– Adding KKLC1 demonstrates the versatility of our TCR-NK platform and supports a multi-asset development strategy, which is critical for long-term value creation and attractive to both partners and investors.

- Overall, we are building a durable off-the-shelf cell therapy company with a pipeline, not a single-asset story. Diversifying targets early ensures strategic resilience, scientific breadth, and a clear path to multiple clinical opportunities.

Despite operational delivery, the market seems to apply a confidence discount to the stock. What is your strategy to bridge this gap and prove to investors that the 'new' Zelluna warrants a re-rating?

- We recognize that the market is still calibrating to the "new" Zelluna, and that confidence is earned, not assumed. Our strategy to close this gap is straightforward: consistent delivery, transparency, and clinical execution.

– Our priorities are to:

• Advance ZI-MA4-1 into the clinic,
• Demonstrate that our TCR-NK platform performs exactly as intended,
• Continue strengthening our pipeline and Business Development footprint, and
• Communicate clearly and consistently with the market as milestones are reached

- As we convert our preclinical success into clinical evidence, we expect the valuation to increasingly reflect the underlying fundamentals and long-term potential of the company.

What are the key milestones investors should look out for over the next 12 months?

– The next 12 months will be an exceptionally active period for Zelluna, with several key milestones that we believe will drive significant value:

• CTA submission and anticipated approval for ZI-MA4-1 in the UK
• First patient dosed in the ZIMA-101 Phase I trial
• Initial clinical data from the early dose-escalation cohorts
• Further preclinical updates across our TCR-NK pipeline, including progress with the newly acquired KKLC1 portfolio
• Potential strategic partnerships as our clinical program and platform validation advance

- Collectively, these milestones represent our transition from a preclinical innovator to a clinical-stage, platform-driven off-the-shelf cell therapy company.

– We are now entering the most important and a very exciting phase of our journey – demonstrating the clinical potential of first-in-class TCR-NK therapies in patients.