OSE Immunotherapeutics: Clinical Milestones and Governance Clarity Fuel Near-Term Upside

OSE Immunotherapeutics (OSE:PA) stands at a pivotal juncture, with recent clinical advancements and governance developments positioning the company to unlock significant near-term value. The TEDOPaM Phase 2 pancreatic cancer data and the postponement/rescheduling of its shareholder meeting highlight catalysts that could redefine investor sentiment and drive valuation upside. Below, we dissect the strategic drivers and assess the risks and rewards for shareholders.

Clinical Progress: A Breakthrough in Pancreatic Cancer and Beyond

The June 2025 TEDOPaM trial results for Tedopi® in pancreatic cancer are a landmark achievement. The combination of Tedopi® with FOLFIRI chemotherapy delivered a 65% one-year survival rate, surpassing the 50% target and outperforming historical benchmarks (median OS of 10-12 months). The trial also reported two complete responses, a stark contrast to the placebo arm. Crucially, Tedopi® demonstrated minimal toxicity, with only 6% of serious adverse events attributed to the drug.

These results are transformative for pancreatic ductal adenocarcinoma (PDAC), a disease with a five-year survival rate of just 10%. Tedopi®'s ability to induce complete responses in a historically intractable cancer suggests it could redefine first-line treatment paradigms. The trial's follow-up—particularly translational analyses via the IMMUNOPANC-Sign program—will refine biomarkers to identify responders, further de-risking Tedopi®'s path to market.

The ARTEMIA Phase 3 trial in NSCLC remains on track, with enrollment across 144 global sites. Expected to report in 2027, this trial aims to validate Tedopi® as a second-line therapy for anti-PD-(L)1-resistant patients, a population with limited options and a high unmet need. Combined with the pancreatic cancer data, Tedopi® is now a dual-therapy candidate in two major oncology markets, amplifying its commercial potential.

Governance Uncertainty and the Path to Clarity

The postponement of OSE's shareholder meeting to September 30, 2025, resolves a critical governance overhang. A shareholder group holding 24% of voting rights sought to overhaul the Board, a move OSE's leadership argued could destabilize ongoing clinical trials and partnerships. The rescheduling, approved by the Nantes Commercial Court, ensures procedural fairness while buying time to address the dispute.

The stock surged 18% on the TEDOPaM data release (June 2), but governance concerns limited gains. A positive resolution in September could unlock further upside.

The Company has countered misinformation head-on, publishing a detailed “Questions and Answers” document and denying rumors of financial mismanagement. CEO Nicolas Poirier's emphasis on transparency—coupled with the Board's commitment to operational continuity—reduces the risk of a leadership shakeup derailing Tedopi®'s development. Legal actions against the shareholder group aim to ensure compliance with transparency principles, reinforcing investor confidence.

Financial Resilience and Strategic Positioning

OSE's €90 million in non-dilutive funding (as of April 30, 2025) provides ample runway to advance Tedopi® and its other programs, such as lusvertikimab (a checkpoint inhibitor with a predictive biomarker in urothelial cancer). This cash position avoids equity dilution, preserving shareholder value during the critical trial-readout period.

Strong liquidity supports clinical trials and global expansion, with no urgent need for financing.

The pipeline's precision medicine focus aligns with industry trends favoring biomarker-driven therapies. Tedopi®'s “pipeline-in-a-product” design—targeting multiple cancers through neo-epitopes—could yield additional indications, extending its commercial life. Meanwhile, lusvertikimab's 30% patient subset with >50% remission potential opens a $3 billion market opportunity, further diversifying OSE's revenue streams.

Catalyst Timeline and Investment Considerations

• September 30, 2025: The rescheduled shareholder meeting will resolve governance uncertainty. A constructive outcome could lift the stock by 10-15%, as lingering disputes no longer cloud the investment thesis.
• 2026: Phase 2 data from CombiTED (NSCLC) and TEDOVA (ovarian cancer) will test Tedopi®'s combination potential, expanding its addressable market.
• 2027: ARTEMIA Phase 3 results and lusvertikimab's Phase 2b data will determine regulatory paths and commercial viability.

Investors should also monitor Tedopi®'s biomarker progress. The identification of predictive factors will be critical to securing approvals and reimbursement. Additionally, OSE's partnerships—such as subcutaneous formulation development—could lower costs and improve patient access, enhancing long-term scalability.

Risk Factors and Valuation Drivers

• Clinical Risks: Tedopi®'s Phase 3 failure in either pancreatic or NSCLC could erase value. However, the pancreatic data's robustness and the NSCLC trial's design mitigate this risk.
• Governance Outcomes: A shareholder victory could introduce leadership instability, though OSE's legal strategy aims to prevent this.
• Market Competition: Immuno-oncology is crowded, but Tedopi®'s neo-epitope approach offers a first-in-class advantage.

At current levels, OSE trades at ~6x its 2027 peak sales estimate for Tedopi®, suggesting upside if the pipeline delivers. A near-term catalyst-driven rerating could push the stock closer to €10–€12, with long-term potential tied to biomarker validation and combination therapies.

Conclusion: A Near-Term Catalyst Play with Long-Term Legs

OSE Immunotherapeutics is a compelling opportunity for investors willing to navigate near-term governance noise. The TEDOPaM data has already validated Tedopi®'s potential in pancreatic cancer, while the rescheduled shareholder meeting removes a key overhang. With a strong balance sheet and a pipeline targeting high-value oncology markets, OSE is poised to deliver meaningful upside as clinical and governance catalysts materialize. Investors should accumulate shares ahead of the September meeting, with a long-term horizon to capture the full value of Tedopi®'s multi-cancer potential.