OSE Immunotherapeutics — New UC biomarker underpins growth strategy

OSE Immunotherapeutics (PAR: OSE)

Last close As at 05/06/2025

EUR6.05

−0.20 (−3.20%)

Market capitalisation

EUR134m

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Research: Healthcare

OSE Immunotherapeutics — New UC biomarker underpins growth strategy

OSE has announced plans to strengthen its growth strategy and accelerate the key pillars of its pipeline, covering immuno-inflammation and immuno-oncology. In the inflammation space, the company revealed a potential path forward for lusvertikimab, which reported positive top-line data in Phase II (CoTikiS) for ulcerative colitis (UC) in Q424. A new predictive biomarker (a composite IL7R axis biomarker) has been identified through a retrospective analysis of CoTikiS, offering potential to improve clinical remission rates through a precision medicine approach with lusvertikimab, for the biomarker-positive population. Management is preparing for a Phase IIb programme to validate this biomarker, with the aim of demonstrating efficacy in this population by 2027. If successful, this should lay the foundation for late-stage clinical development efforts for lusvertikimab. In the oncology space, the latest update confirmed that the company is on track with its plans for regulatory submission, with the pivotal Phase III non-small cell lung cancer trial due to conclude in 2027, with potential to expand the label to other indications (such as pancreatic cancer) in later years, contingent on successful clinical progression.

Jyoti Prakash

Written by

Jyoti Prakash, CFA

Director, healthcare

Healthcare

Strategy update

5 June 2025

Price €6.25
Market cap €133m

Net cash (including current and non-current deposits and lease liabilities) at 31 December 2024

€18.0m

Shares in issue

22.3m
Free float 65.0%
Code OSE
Primary exchange NXT PA
Secondary exchange N/A
Price Performance

Business description

OSE Immunotherapeutics (OSE) is based in Nantes and Paris in France and is listed on the Euronext Paris exchange. It is developing immunotherapies for the treatment of solid tumours and autoimmune diseases and has established several partnerships with large pharma companies.

Analysts

Jyoti Prakash, CFA
+44 (0)20 3077 5700
Arron Aatkar, PhD
+44 (0)20 3077 5700

OSE Immunotherapeutics is a research client of Edison Investment Research Limited

Note: PBT shown is normalised PBT. EPS shown is diluted EPS.

Year end Revenue (€m) PBT (€m) EPS (€) DPS (€) P/E (x) Yield (%)
12/23 2.2 (23.2) (1.18) 0.00 N/A N/A
12/24 83.4 39.8 1.48 0.00 4.2 N/A
12/25e 63.5 27.0 1.23 0.00 5.1 N/A
12/26e 101.5 63.3 2.89 0.00 2.2 N/A

As part of its update on its renewed growth strategy, OSE announced a new predictive biomarker as a potential value lever for lusvertikimab. The candidate showed successful results in the Phase II CoTikiS trial in UC, including relatively high rates of clinical and endoscopic remission. The company announced that its research and translational team, alongside foundational model specialists, have identified a new predicative biomarker using advanced artificial intelligence and transfer learning. The model was trained using retrospective multimodal data from millions of inflammatory disease patients and refined with data from the CoTikiS trial. Management estimates that this biomarker captures approximately a 30% subpopulation of UC patients, offering remission rates in excess of 50%, an improvement over current rates of remission in the inflammatory bowel disease space, which is characterised by a ceiling on therapeutic efficacy.

It was noted that in its data set from CoTikiS, none of the biomarker-negative patients showed clinical remission, suggesting that there could be no loss of treatment opportunity, if lusvertikimab treatment is prioritised based on biomarker status. This paves a potential clinical development path whereby lusvertikimab could be evaluated as a potential first-line treatment for the biomarker-positive UC population, which management estimates could translate to a commercial opportunity worth over $3bn across seven major markets. The company is planning a Phase IIb programme to establish a dose regimen for subsequent registrational studies, explore a subcutaneous formulation and validate this predictive biomarker prospectively. Management aims to complete this by 2027; we will be reviewing our commercialisation timing assumptions for the candidate.

OSE’s lead oncology candidate is Tedopi. A recent update was presented at the ASCO 2025 conference; please refer to our prior note for further details.

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