Northern Lights

Isofol Medical Encouraging progress

The Q2 operating loss of cSEK36m was in line with our estimate of cSEK37.5m. In our view, the main event in Q2 was the encouraging data reported from the extension of the phase I/IIa trial with a best overall response rate of 58%. Furthermore, the company strengthened its patent portfolio with two clinical use patents. Lastly, three new members were elected to the board of directors. We reiterate our fair value of SEK18–49.

Northern Lights

Isofol Medical A step in the right direction

In an extension of its phase I/IIa open-label study, Isofol reported that 11 of 19 patients (58%) responded when measuring the preliminary best overall response rate at 8–32 weeks of treatment. As previous data measured at an 8-week cut-off showed a response in 9 of 19 (47%), the update shows a positive trend. Data outcomes from the ongoing phase III trial, AGENT, will be fundamental in determining the market potential for arfolitixorin.

Northern Lights

Isofol Medical All eyes on AGENT

The main event in Q4 2018 was the initiation of the pivotal phase III study, AGENT; the first patient has now been dosed in this study. Although there might be a slight delay in the top-line readout of AGENT, management’s estimated timing of a launch in 2023 is unchanged. In its Q4 report, the company highlighted that it could charge USD4,000 per patient per month in the US. This brings upside potential to our estimated price of USD3,000 per patient per month in the US. We reiterate our fair v...

Isofol Medical New data in line with expectations

The company has reported efficacy data from 19 patients with advanced colorectal cancer who are enrolled in an extension arm of the ongoing phase I/IIa study ISO-CC-005. Nine of 19 (47%) patients experienced a reduction in tumour size of at least 20%; this was largely in line with our expectations. About a year ago, the company reported data from 12 other patients who had been treated with arfolitixorin; in this readout, seven of 12 (c58%) patients experienced a reduction in tumour size of at le...

Isofol MedicalQ3 results review

We believe Q3 was uneventful, besides Isofol being granted a new patent for arfolitixorin in the US. However, we do not believe this patent increases the probability for arfolitixorin to reach the market, and our discount period already accounts for sales until 2038e. YOY costs have increased significantly YTD, in line with our expectations. The current cash position should be sufficient to cover all costs for the pivotal phase III trial AGENT should Isofol proceed with the original development ...

Isofol Medical

Recruitment timeline for phase III

Isofol MedicalWaiting for initiation of phase III

The Q2 report was a non-event, as is usually the case for biotech companies in the development phase. The next potential catalyst will be the FDA’s approval of the company’s special protocol agreement (SPA) and subsequent initiation of the phase III trial, ISO-CC-007, in October. We have not made any changes to our forecasts and reiterate our fair value of SEK18–49.

Isofol MedicalIt’s all about the data

Colorectal cancer (CRC) is one of the largest cancer markets where chemotherapy is a backbone therapy. Today, c365,000 patients on chemotherapy treatment also receive folate-based drugs to enhance the cytotoxic effect. Isofol Medical aims that its key drug candidate, arfolitixorin, will become the preferred folate-based therapy as a standard of care therapy in CRC treatment.