Analyst Comment

Aselia pharma: Partnering discussions for Orviglance continues to advance

Summary

Ascelia Pharma's Q4 2025 results highlight the FDA's acceptance of the Orviglance NDA, with a PDUFA decision date set for 3 July 2026.
The company reported an operating loss of SEK –15.8m, reflecting reduced R&D spending, and cash reserves declined to SEK 49.9m, extending the runway into Q4 2026.
Partnering discussions for Orviglance have gained momentum, but no concrete partnerships have been announced, making this a key focus alongside the FDA decision.
Deputy CEO Julie Waras Brogren's departure is notable ahead of potential approval and launch, with 2026 expected to be transformative for Ascelia.

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This morning, Ascelia Pharma (ACE) published its Q4 2025 and full-year results. The key development in news flow since Q3 was the FDA's formal acceptance of the Orviglance NDA via the 'Day 74 letter' in mid-November, which set a concrete PDUFA decision date of 3 July 2026.

Beyond the NDA acceptance, the quarter was operationally quiet. Ascelia filed a new patent application for Orviglance during Q4, though details were not disclosed. The operating loss of SEK –15.8m (vs. –21.9m in Q4 2024) reflects lower R&D spending post-NDA submission. Cash declined from SEK 72.3m to SEK 49.9m, in line with the company's burn rate, and management reiterates that the runway extends into Q4 2026.

The narrative around partnering remains largely unchanged from Q3. Management states that dialogues have "gained additional momentum and clarity" following the established regulatory timeline, but no concrete partner announcements have been made. This remains the key value driver to watch alongside the FDA decision.

Post-period, Ascelia announced that Deputy CEO Julie Waras Brogren will leave the company. Given her commercial and IR responsibilities, the timing ahead of a potential approval and launch is notable, though no further details were provided.

Looking ahead, 2026 is positioned as a "transformative" year for Ascelia, with the FDA decision and a potential US launch with a commercialization partner as the key milestones. Until then, the investment case remains in a broader range, approval and partner economics will determine value, while the current cash position provides runway through the decision date.

Tomorrow we will host an event with CEO Magnus Corfitzen, where he will present the financial results for 2025 and provide an update on the company’s latest developments.

https://www.inderes.dk/videos/ascelia-pharma-presentation-of-fy-2025-results

Disclaimer: HC Andersen Capital receives payment from Ascelia Pharma for a DigitalIR/Corporate Visibility subscription agreement. / Michael Friis 12:42 05/02/2026

Ascelia Pharma is a Swedish biotech company with a focus on orphan oncology treatments. They develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. Currently, Ascelia pharma has two pipeline products, namely Orviglance and Oncoral. Orviglance is a novel contrast agent for MR-Imaging developed to improve the detecting and visualization of focal liver lesions (Including liver metastases – and primary tumors) in patients with reduced kidney function. Oncoral is a daily tablet with an established potent anti-tumor effect – even in difficult to treat cancers with the potential to offer better patient outcomes with improved safety following a daily tablet treatment compared to intravenous high-dose infusions at the hospital. Ascelia Pharma is listed on Nasdaq Small Cap Stockholm with ticker ACE.