Quarterly Report Q3 2026: Orviglance® update following FDA Type A meeting

KEY EVENTS IN Q3 2026

• Publication of Orviglance clinical study in Journal of Magnetic Resonance Imaging
• FDA Type A meeting completed on 9 September
• Ascelia Pharma receives a Complete Response Letter from the U.S. Food and Drug Administration
• CFO Anton Hansson is leaving the company, alongside measures to reduce the cost base

KEY EVENTS AFTER THE PERIOD

• Official minutes from Type A meeting with the FDA received

FINANCIAL SUMMARY Q3 (Jul-Sep) 2026

• Operating result of SEK -10.4M (SEK -15.3M)
• Earnings per share of SEK -0.08 (SEK -0.13)
• Cash flow from operations of SEK -10.1M (SEK -15.7M)
• Liquid assets and marketable securities of SEK 27.8M (SEK 72.3M)

“At the beginning of September, we completed a Type A meeting with the FDA following the receipt of a Complete Response Letter (CRL) regarding our New Drug Application (NDA) for Orviglance. The meeting provided an opportunity to discuss the issues raised by the FDA in the CRL and to gain further clarity on the regulatory path forward.

In October, we received the official meeting minutes. FDA acknowledged both the unmet medical need and the positive safety profile, as well as Orviglance technical performance as a T1-enhancing contrast agent. Although the FDA maintains that approval requires additional clinical evidence from a new study, it acknowledged that such evidence could potentially be generated through a prospective analysis of Phase 3 SPARKLE images using a different primary endpoint.

Based on the FDA’s feedback, we are currently evaluating the most efficient path forward for Orviglance in the U.S., focusing on alternatives that build on the existing SPARKLE dataset. We believe that the existing clinical data package provides a strong foundation for the continued pursuit of regulatory approval.

Following the receipt of the CRL, we implemented cost-saving measures that have strengthened our cash position and increased our financial flexibility, enabling us to support the activities required to advance the regulatory process. Other key priorities ahead will be to advance regulatory activities in Europe and continue the partnering process. We believe that the commercial opportunity for Orviglance remains attractive, and our partnering process continues to progress.

We remain confident that the totality of evidence generated throughout the development program supports Orviglance’s efficacy and safety and remain fully committed to making Orviglance available to patients with severe kidney impairment.”, said Magnus Corfitzen, CEO at Ascelia Pharma.
 
A presentation for analysts, investors and media will be held today 5 November 2026 at 10:00am CET. The event will be hosted by the company’s CEO Magnus Corfitzen and CSO Andreas Norlin. The presentation will be held in English. The presentation can be followed live via the link: Q3 Report 2026

To participate via teleconference, please register through the link below. After registration, you will be provided with phone numbers and a conference ID to access the conference. Call Access

It will also be possible to access the audiocast afterwards at the same address or on the website of Ascelia Pharma: IR & Media – ASCELIA