The information in the press release is intended for investors.
- Net revenue amounted to TSEK 2,907 (5,154) and other revenue to TSEK 0 (0)
- The result for the period amounted to TSEK -32,513 (-51,026)
- Earnings per share amounted to SEK -0.20 (-0.32)
- Cash and cash equivalents as of September 30 amounted to TSEK 234,983 (420,861)
- Net revenue amounted to TSEK 10,940 (17,702) and other revenue to TSEK 1 (0)
- The result for the period amounted to TSEK -134,420 (-139,081)
- Earnings per share amounted to SEK -0.83 (-1.22)
- On July 26, Isofol received approval of a biomarker analysis patent.
- On August 3, Isofol presented the top-line results of the global pivotal phase III AGENT study. The study data revealed that the study did not achieve the primary endpoint of objective response rate (ORR) or the key secondary endpoint of progression-free survival (PFS).
- On August 31, Isofol announced that based on additional study data, there was no longer reason to continue with the AGENT study. The conclusions regarding primary and secondary endpoints will not be revised. Isofol's Board resolved to assess possible alternatives for the company's future.
- On September 7, Isofol reported additional study data that laid the groundwork for the decision to terminate the study early. In parallel with this decision, Isofol's Board will continue to investigate possible alternatives to secure the largest possible value for Isofol's shareholders.
- No significant events occurred after the end of the period.
" Given the AGENT study results' low clinical and business value for Isofol, we began work during the quarter to terminate the study. This must be carried out in accordance with applicable ethical aspects and regulatory requirements. This work is extensive and will therefore require both time and resources throughout autumn 2022 and the beginning of 2023. We also took active measures to reduce costs and secure the company's financial position, which has been our utmost priority along with finding any positive outcomes in the study data and terminating the study", says CEO Ulf Jungnelius.
Audiocast, November 11, at 11:00 a.m. CET
In conjunction with the publication of the interim report for the third quarter of 2022, Isofol invites investors, analysts, and media to an audiocast on November 11, 2022 at 11:00 a.m. CET. The presentation will be held by Isofol's CEO Ulf Jungnelius and CFO Gustaf Albèrt, who will present and comment the report, followed by a Q&A-session. The presentation will be held in English.
Date and time
November 11, 2022, at 11:00 a.m. CET
To participate via telephone, please dial one of the numbers below.
SE: +46 8 50 55 83 69
UK: +44 333 300 92 68
US: +1 631 913 1422, PIN: 46897527#
The presentation will also be available on Isofol's website after the broadcast:
For more information, please contact
Isofol Medical AB (publ)
Ulf Jungnelius, M.D., CEO
Telephone: +46 709-16 89 55
Gustaf Albèrt, CFO
Telephone: +46 709-16 83 02
The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CET, on November 11, 2022.
About Isofol Medical AB (publ)
Isofol Medical AB (publ) is a clinical stage biotech company that is progressing and advancing current standards of care for people living with cancer by working to improve the efficacy of the current chemotherapeutic standards of care. Isofol is focused on developing a drug for the first line treatment of metastatic colorectal cancer (mCRC) and seeks to elevate current clinical practice by unlocking the full strength of 5-FU with the addition of arfolitixorin. Isofol holds a worldwide exclusive licensing agreement with Merck & Cie, Schaffhausen, Germany to develop and commercialize arfolitixorin for use in oncology. Isofol Medical AB (publ) is traded on Nasdaq, Stockholm.