Annual Report 2024: Orviglance Advances to Registration Phase after Successful Phase 3 Study Completion

Ascelia Pharma AB (publ) (ticker: ACE) today published its Annual Report 2024, which is now available on the company’s website.

Magnus Corfitzen, CEO, Ascelia Pharma, says: In 2024, we met several major milestones for our lead asset Orviglance. We announced a successful outcome of the pivotal Phase 3 study, SPARKLE, with positive headline results and subsequent Full Study Report which mark the completion of the clinical development of Orviglance. The results showed that Orviglance significantly improved visualization of focal liver lesions, successfully meeting the primary endpoint with statistical significance for all three readers (<0.001). The results of the secondary endpoint analysis further reinforce the successful study outcomes and support the New Drug Application (NDA) process and potential clinical value of Orviglance.

In March 2025, we announced the outcomes from a planned meeting with the US Food and Drug Administration
(FDA), providing positive guidance for the Orviglance NDA in order to progress with the submission mid-2025 as
planned. We are in a strong position to execute on our key priorities in 2025; to submit the NDA and to continue the
dialogue with potential partners for the commercialization of Orviglance and make it available to patients in need of
a high-quality liver imaging option without gadolinium related safety risks.

It’s encouraging to see how the medical community has welcomed Orviglance with the acceptance of SPARKLE
Phase 3 data for presentation in four oral presentations and three abstracts at key scientific conferences thus far.

With the fully subscribed SEK 105 million Rights Issue financing in Q3 2024, our cash runway extends until late 2025;
well beyond the NDA submission for Orviglance. Our runway can furthermore be significantly extended during 2025
with financing from warrants and partnering.”