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Kursutveckling och likviditet under dagen för detta pressmeddelande

Beskrivning

LandSverige
ListaMid Cap Stockholm
SektorHälsovård
IndustriBioteknik
Isofol Medical är verksamma inom bioteknik. Bolaget bedriver störst forskning och utveckling inom onkologi. Bolaget utvecklar cancerläkemedel och läkemedelskandidater som främst är avsett för behandling av kolorektalcancer (CRC), en av de vanligaste formerna av cancer. Utöver huvudverksamheten utvecklar bolagen även så kallade räddningsbehandling efter högdosbehandling med cellgiftet metotrexat vid osteosarkom (bencancer).

Kalender

2023-02-23 Bokslutskommuniké 2022
2022-11-11 Kvartalsrapport 2022-Q3
2022-08-23 Kvartalsrapport 2022-Q2
2022-05-20 Ordinarie utdelning ISOFOL 0.00 SEK
2022-05-19 Årsstämma 2022
2022-05-12 Kvartalsrapport 2022-Q1
2022-02-25 Bokslutskommuniké 2021
2021-11-15 Kvartalsrapport 2021-Q3
2021-08-24 Kvartalsrapport 2021-Q2
2021-06-23 Årsstämma 2021
2021-05-21 Ordinarie utdelning ISOFOL 0.00 SEK
2021-05-20 Kvartalsrapport 2021-Q1
2021-05-14 Extra Bolagsstämma 2021
2021-02-26 Bokslutskommuniké 2020
2020-11-13 Kvartalsrapport 2020-Q3
2020-08-21 Kvartalsrapport 2020-Q2
2020-06-25 Ordinarie utdelning ISOFOL 0.00 SEK
2020-06-24 Årsstämma 2020
2020-05-14 Kvartalsrapport 2020-Q1
2020-05-05 Extra Bolagsstämma 2020
2020-02-19 Bokslutskommuniké 2019
2019-11-13 Kvartalsrapport 2019-Q3
2019-08-22 Kvartalsrapport 2019-Q2
2019-05-24 Ordinarie utdelning ISOFOL 0.00 SEK
2019-05-23 Kvartalsrapport 2019-Q1
2019-05-23 Årsstämma 2019
2019-02-26 Bokslutskommuniké 2018
2018-12-17 Extra Bolagsstämma 2018
2018-11-14 Kvartalsrapport 2018-Q3
2018-08-21 Kvartalsrapport 2018-Q2
2018-05-16 Kvartalsrapport 2018-Q1
2018-05-04 Ordinarie utdelning ISOFOL 0.00 SEK
2018-05-03 Årsstämma 2018
2018-02-20 Bokslutskommuniké 2017
2017-11-20 Kvartalsrapport 2017-Q3
2017-08-21 Kvartalsrapport 2017-Q2
2017-05-16 Årsstämma 2017
2017-05-16 Kvartalsrapport 2017-Q1
2021-12-06 19:48:04

Late last Friday, Isofol announced that the 300 PFS events triggering the analysis of the data of the ongoing phase III study will not be reached due to unusually high censoring of patients. The news sent the stock tumbling 27%. We understand the initial confusion in the market but highlight that this news should not negatively affect the possibility of a potential approval; nevertheless, the top line results might be delayed by a few months. We await the company's analysis before making any adjustments to our assumptions.

Will not reach 300 PFS events due to unusually high censoring. Late last Friday, the company announced that 300 PFS events would not be reached in the ongoing phase III study due to a higher-than-expected number of patients being censored, as the result of patients proceeding to other treatments before reaching PFS. The company had requested to adjust the censoring rules according to the latest guidelines (adopted by the FDA in 2021), but the request was denied. The stock plunged 27% as markets opened today.

Confusion understandable, but this should not hinder a potential approval. The company has previously highlighted 300 PFS events as the next milestone that would trigger the unblinding and analysis of data; the announcement that this would not be reached understandably created some confusion in the market. However, we note the following: Firstly, the primary objective, of showing ≥10%-points improvement in ORR over SoC, is not affected. Secondly, the secondary objective is to show a positive trend in PFS. While the current censoring rules probably make it difficult to show any statistically significant change in PFS, this was never a requirement from the FDA. Thirdly, the iDSMB has repeatedly examined the data and reported no safety issues.

Top-line results probably somewhat delayed. The company and the FDA are still blind to the data and it will fall to an independent clinician to try to understand what could have caused the large censoring. While the cause remains to be determined, during a call management speculated that some patients might have been wrongly censored. Once the company has analysed and understood the impact and options, it intends to seek feedback from the FDA and agree on a new trigger point to start the analysis. Visibility is low, but our best guess is that there will be a few months' delay in top-line results (previously expected in H1 2022).

Fair value of SEK13-23 reiterated. We await further information from the company's analysis before making any adjustments to our fair value.

Click here to view full report (https://www.dnb.no/seg-fundamental/fundamentalweb/GetReports.aspx?file=CMPSP_186027.pdf&Sid=1-7XT0MIJ)

Best regards 
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David Martinsson | Markets | Equity Research | Healthcare

Patrik Ling | DNB Markets | Equity Research | Senior Analyst Healthcare
DNB Bank ASA
Regeringsgatan 59 | Stockholm | Sweden