Zelluna Q1 2025 slides highlight TCR-NK manufacturing breakthrough post-merger

Published 08/05/2025, 06:04
Zelluna Q1 2025 slides highlight TCR-NK manufacturing breakthrough post-merger

Introduction & Market Context

Zelluna ASA (OSE:ZLNA) presented its Q1 2025 business update on May 8, 2025, highlighting significant developments following its recent business combination with Ultimovacs ASA. The company’s stock has shown positive momentum, rising 7.3% to 14.7 NOK ahead of the presentation.

As a pioneer in TCR-NK cell therapy, Zelluna is positioning itself in the rapidly evolving cell therapy landscape, where recent acquisitions have commanded significant premiums. The company specifically highlighted AstraZeneca (NASDAQ:AZN)’s approximately $1 billion acquisition of EsoBiotec and Roche’s approximately $1.5 billion acquisition of Poseida as benchmarks for valuations in the space.

As shown in the following context slide, Zelluna is developing next-generation cell therapies targeting solid tumors, an area where current therapies have struggled to deliver long-term responses:

Strategic Initiatives

The first quarter of 2025 was transformative for Zelluna, marked by the completion of its business combination with Ultimovacs ASA on March 3, 2025, accompanied by a private placement of MNOK 51.7. Following the transaction, Ultimovacs ASA acquired all shares in Zelluna Immunotherapy AS and changed its name to Zelluna ASA, with the ticker symbol ZLNA.

On March 4, 2025, Zelluna became the first cell therapy company to be listed on the Oslo Stock Exchange, marking a significant milestone in the company’s history:

Perhaps the most significant operational development came on April 22, 2025, when Zelluna announced it had established a manufacturing process for its lead TCR-NK therapy, ZI-MA4-1, targeting solid tumors. This represents a critical de-risking step in preparation for clinical trials:

The company’s manufacturing approach is designed for scalability, with the potential to produce hundreds of doses from a single manufacturing batch, enabling treatment of multiple patients with multiple doses each:

Quarterly Performance Highlights

Zelluna’s pipeline consists of three main programs: ZI-MA4-1 targeting MAGE-A4, ZI-KL1-1 targeting KK-LC-1, and ZI-PR-1 targeting PRAME. These programs are being developed for various solid tumor indications including non-small cell lung cancer, ovarian cancer, breast cancer, and others:

The company’s TCR-NK platform combines T Cell Receptors (TCRs) with Natural Killer (NK) cells to create a novel therapeutic approach. According to Zelluna, this combination leverages the targeting capabilities of TCRs with the potent killing mechanisms of NK cells:

Zelluna provided an update on the MultiClick Technology and UV1 Program inherited from Ultimovacs. Three of the Phase II trials for UV1 in malignant melanoma, mesothelioma, and head and neck cancer have been completed with disappointing results, leading to the decision to wrap up the program. However, two remaining trials, LUNGVAC and DOVACC, have completed enrollment with topline results expected during 2025.

Detailed Financial Analysis

Zelluna reported key financial metrics for Q1 2025, including a cash position of MNOK 135 (approximately USD 13 million) at the end of the quarter. With the recently completed private placement, the company expects its financial runway to extend through Q2 2026, capturing the key IND catalyst for its TCR-NK technology:

The company reported an EBIT of MNOK -29 and profit before tax of MNOK -28 for Q1 2025. Notably, operating expenses decreased to MNOK 29.3 in Q1 2025 from MNOK 35.8 in Q1 2024, representing an improvement in cost management:

The operating cash flow in Q1 2025 was approximately MNOK -36, with the difference from EBIT primarily due to share option expenses with no cash effect and changes in working capital:

It’s important to note that the financial information for Q1 2025 reflects Zelluna Immunotherapy AS for January through March, plus the rest of the Zelluna group for March only, following the business combination.

Forward-Looking Statements

Zelluna outlined several key upcoming milestones that could serve as value inflection points. In the second half of 2025, the company expects to complete preclinical work, begin GMP manufacturing, and submit IND/CTA applications. Initial clinical readouts are anticipated in the first half of 2026:

The company emphasized that its strong IP position provides an opportunity to establish dominance in the TCR-NK therapeutic field. Zelluna compared this to "owning the CAR-T space," suggesting significant value creation potential:

Zelluna’s management believes the company is at an inflection point, with its lead program approaching clinical stage and a pathway validated through pre-IND discussions with the FDA. The company highlighted that approval paths in cell therapy can be relatively fast, requiring data from fewer than 100 patients, and that high-value deals in the space have been based on relatively small clinical datasets.

With its manufacturing process now established and financial runway extended through Q2 2026, Zelluna appears positioned to advance its novel TCR-NK platform toward clinical validation, potentially capturing significant value in the rapidly evolving cell therapy landscape.

Full presentation:

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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