On February 24, 2022 Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), reported that the company’s year-end report for January – December 2021 is now available on the company’s website, www.isofolmedical.com (View Source) (Press release, Isofol Medical, FEB 24, 2022, View Source [SID1234608930]).
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Fourth quarter, October –December 2021
Net revenue amounted to TSEK 4,704 (18,680) and other revenue to TSEK 0 (18)
The result for the period amounted to TSEK -61,170 (-54,659)
Earnings per share amounted to SEK -0.38 (-0.66)
Cash and cash equivalents on December 31 amounted to TSEK 379,448 (116,393)
January – December 2021
Net revenue amounted to TSEK 22,407 (37,119) and other revenue to TSEK 0 (18)
The result for the period amounted to TSEK -200,251 (-188,992)
Earnings per share amounted to SEK -1.59 (-3.07)
The Board of Directors proposes that no dividend will be paid for the 2021 financial year
Significant events during the fourth quarter 2021
On October 21, Isofol’s shares were listed on Nasdaq Stockholm.
Isofol was granted Fast Track Designation by the US Food and Drug Administration (FDA) for arfolitixorin for the treatment of advanced colorectal cancer (CRC).
Isofol announced that the FDA denied a request from the company to adjust the censoring rules for the ongoing AGENT study’s secondary endpoint after more patients than expected proceeded to other treatments before they reached tumor progression (PFS). However, the study’s primary endpoint, objective response rate (ORR), was not affected and an agreement for a new cut-off point for top-line results is expected in spring 2022.
Significant events after the event of the period
Jenny Sundqvist assumed her role as Chief Commercial Officer on January 1, 2022.
VD´s comment:
"In the fourth quarter of 2021, efforts to establish the best possible conditions ahead of a future commercial launch continued. The Fast Track Designation that we received will be valuable for us in this regard as we complete the final stages of the AGENT study, as it enables among other things more frequent dialogue with the FDA. Finally, we are proud to have written a new chapter in Isofol’s history and raised more awareness of the company through the listing in the MidCap segment of Nasdaq Stockholm’s main market in October." says CEO Ulf Jungnelius.
The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CET, on February 24, 2022.
About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global pivotal Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.