Quarterly Report Q1 2026: Orviglance® Approaching Transformative Milestones

KEY EVENTS IN Q1 2026

• Abstract with Orviglance data has been accepted for oral presentation at the annual radiology congress ESGAR 2026
• Management changes: Anton Hansson starts as CFO, while Julie Waras Brogren leaves her position as Deputy CEO

KEY EVENTS AFTER THE PERIOD

• Ascelia Pharma completes directed share issue of SEK 20 million before transaction costs

FINANCIAL SUMMARY Q1 (Jan-Mar) 2026

• Operating result of SEK -17.2M (SEK -20.3M)
• Earnings per share of SEK -0.13 (SEK -0.23)
• Cash flow from operations of SEK -15.9M (SEK -16.9M)
• Liquid assets and marketable securities of SEK 33.9M (SEK 57.3M)

“Orviglance® is on track for approval on the July 3 PDUFA date. FDA’s review of our New Drug Application (NDA) progressed as planned during the quarter, and we remain fully engaged in a constructive, transparent dialogue with the agency as we approach the final month of the review.

The NDA submission is based on the successful completion of a development program, which includes nine clinical studies with consistent positive efficacy and safety results. In our Phase 3 study, SPARKLE, Orviglance significantly improved visualization of focal liver lesions in patients with impaired kidney function, meeting the primary endpoint with statistical significance for all three readers.

During the quarter, we received additional scientific validation as an abstract containing data from Orviglance was accepted for an oral presentation at the annual radiology congress ESGAR 2026, further strengthening the product's clinical and scientific profile.

Following the end of this quarter, we have strengthened our balance sheet. In April 2026, we successfully completed a directed share issue generating proceeds of SEK 20 million before transaction costs. The capital raise was undertaken to proactively solidify our negotiation position in partnering discussions and extend our cash runway into 2027.

In parallel, our commercial partnering process continues to advance, and we are engaged in multiple discussions with potential partners that demonstrate strong strategic interest. With additional liquidity, our flexibility is enhanced and as we approach the PDUFA date, we remain well-positioned to secure a partnering agreement.”, said Magnus Corfitzen, CEO at Ascelia Pharma.
 
A presentation for analysts, investors and media will be held today 12 May 2026 at 10:00am CET. The event will be hosted by the company’s CEO Magnus Corfitzen, CFO Anton Hansson and CSO Andreas Norlin. The presentation will be held in English. The presentation can be followed live via the link: 
Q1 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