MALMÖ, SE / ACCESS Newswire / August 20, 2026 / Ascelia Pharma (STO:ACE) today published its Half-Year Report for 2026 (January - June), which is now available on the company's website: Financial Reports - ASCELIAKEY EVENTS IN Q2 2026Ascelia Pharma completed a directed share issue of SEK 20 million before transaction costsBulletin from the Annual General Meeting in Ascelia Pharma AB on 4 May 2026Orviglance data presented at the Annual Radiology Congress ESGAR 2026Orviglance IP Portfolio expanded with new patent filingKEY EVENTS AFTER THE PERIODAscelia Pharma receives a Complete Response Letter from the U.S. Food and Drug Administration regarding the Company's New Drug Application for OrviglanceAscelia Pharma announces CFO Anton Hansson's departure, alongside measures to reduce the cost baseAscelia Pharma announces that FDA has scheduled a Type A meeting on September 9, 2026FINANCIAL SUMMARY Q2 (Apr-Jun) 2026Operating result of SEK -12.1M (SEK -23.0M)Earnings per share of SEK -0.09 (SEK -0.20)Cash flow from operations of SEK -14.0M (SEK -18.0M)Liquid assets and marketable securities of SEK 38.0M (SEK 60.4M)"Our focus in the second quarter was on facilitating the finalization of the U.S. Food and Drug Administration (FDA) regulatory review of Orviglance® and preparing the partnering dialogues for entering into a deal following approval of Orviglance.Shortly after the quarter ended, we received a Complete Response Letter (CRL) from the FDA regarding our New Drug Application (NDA) for Orviglance. This was an unexpected outcome of the review process, but it has not changed our confidence in Orviglance and its potential to address a significant unmet medical need. The Ascelia Pharma team and I remain fully committed to making Orviglance available to patients with severe kidney impairment who require safe and effective liver imaging.We have submitted a request for a Type A meeting with the FDA to clarify the matters outlined in the CRL and align with the FDA on the path forward. The FDA has accepted the meeting request, and the meeting is scheduled for 9 September. Official meeting minutes are expected to be provided by the FDA within 30 days following the meeting.We believe the completed clinical development program, including the positive Phase 3 SPARKLE results, supports approvability of Orviglance. We will continue to engage constructively with the FDA and will provide further updates as we gain greater clarity on the regulatory path ahead.Following the receipt of the CRL, we implemented cost-saving measures to reduce our cash burn rate and strengthen liquidity, providing increased financial flexibility to support the work required to address issues raised in the CRL," said Magnus Corfitzen, CEO at Ascelia Pharma.A presentation for analysts, investors and media will be held today 20 August 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: Q2 Report 2026To 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 accessIt will also be possible to access the audiocast afterwards at the same address or on the website of Ascelia Pharma: IR & Media - ASCELIAAbout usAscelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates - Orviglance and Oncoral - in development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit http://www.ascelia.com.ContactsMagnus Corfitzen, CEOEmail: moc@ascelia.comTel: +46 735 179 118Anton Hansson, CFOEmail: anton.hansson@ascelia.comTel: +46 735 179 113This information was submitted for publication, through the agency of the contact persons set out above.This information is information that Ascelia Pharma is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-08-20 07:30 CEST.AttachmentsAscelia Pharma Q2 2026 ENSOURCE: Ascelia PharmaView the original press release on ACCESS Newswire
Focus on The Path Forward for Orviglance
MALMÖ, SE / ACCESS Newswire / August 20, 2026 / Ascelia Pharma (STO:ACE) today published its Half-Year Report for 2026 (January - June), which is now available on the company's website: Financial Reports - ASCELIAKEY EVENTS IN Q2 2026Ascelia Pharma completed a directed share issue of SEK 20 million before transaction costsBulletin from the Annual General Meeting in Ascelia Pharma AB on 4 May 2026Orviglance data presented at the Annual Radiology Congress ESGAR 2026Orviglance IP Portfolio expanded with new patent filingKEY EVENTS AFTER THE PERIODAscelia Pharma receives a Complete Response Letter from the U.S. Food and Drug Administration regarding the Company's New Drug Application for OrviglanceAscelia Pharma announces CFO Anton Hansson's departure, alongside measures to reduce the cost baseAscelia Pharma announces that FDA has scheduled a Type A meeting on September 9, 2026FINANCIAL SUMMARY Q2 (Apr-Jun) 2026Operating result of SEK -12.1M (SEK -23.0M)Earnings per share of SEK -0.09 (SEK -0.20)Cash flow from operations of SEK -14.0M (SEK -18.0M)Liquid assets and marketable securities of SEK 38.0M (SEK 60.4M)"Our focus in the second quarter was on facilitating the finalization of the U.S. Food and Drug Administration (FDA) regulatory review of Orviglance® and preparing the partnering dialogues for entering into a deal following approval of Orviglance.Shortly after the quarter ended, we received a Complete Response Letter (CRL) from the FDA regarding our New Drug Application (NDA) for Orviglance. This was an unexpected outcome of the review process, but it has not changed our confidence in Orviglance and its potential to address a significant unmet medical need. The Ascelia Pharma team and I remain fully committed to making Orviglance available to patients with severe kidney impairment who require safe and effective liver imaging.We have submitted a request for a Type A meeting with the FDA to clarify the matters outlined in the CRL and align with the FDA on the path forward. The FDA has accepted the meeting request, and the meeting is scheduled for 9 September. Official meeting minutes are expected to be provided by the FDA within 30 days following the meeting.We believe the completed clinical development program, including the positive Phase 3 SPARKLE results, supports approvability of Orviglance. We will continue to engage constructively with the FDA and will provide further updates as we gain greater clarity on the regulatory path ahead.Following the receipt of the CRL, we implemented cost-saving measures to reduce our cash burn rate and strengthen liquidity, providing increased financial flexibility to support the work required to address issues raised in the CRL," said Magnus Corfitzen, CEO at Ascelia Pharma.A presentation for analysts, investors and media will be held today 20 August 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: Q2 Report 2026To 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 accessIt will also be possible to access the audiocast afterwards at the same address or on the website of Ascelia Pharma: IR & Media - ASCELIAAbout usAscelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway. The company has two drug candidates - Orviglance and Oncoral - in development. Ascelia Pharma has global headquarters in Malmö, Sweden, and is listed on Nasdaq Stockholm (ticker: ACE). For more information, please visit http://www.ascelia.com.ContactsMagnus Corfitzen, CEOEmail: moc@ascelia.comTel: +46 735 179 118Anton Hansson, CFOEmail: anton.hansson@ascelia.comTel: +46 735 179 113This information was submitted for publication, through the agency of the contact persons set out above.This information is information that Ascelia Pharma is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-08-20 07:30 CEST.AttachmentsAscelia Pharma Q2 2026 ENSOURCE: Ascelia PharmaView the original press release on ACCESS Newswire
Ascelia Pharma received an FDA Complete Response Letter for Orviglance, scheduling a Type A meeting on September 9 and cutting costs. Regulatory delays in biotech compress runway; the setback doesn't block approval pathways but forces resource reallocation.
