Isofol Medical AB: 1 director

A director at Isofol Medical AB bought 500,000 shares at 0.610SEK and the significance rating of the trade was 53/100. Is that information sufficient for you to make an investment decision? This report gives details of those trades and adds context and analysis to them such that you can judge whether these trading decisions are ones worth following. Included in the report is a detailed share price chart which plots discretionary trades by all the company's directors over the last two years cle...

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Isofol Medical Full steam ahead

Isofol Medical had a pivotal Q3 in terms of clinical and commercial milestones. We expect results from the interim readout in Q1 2021e and the DSMB to recommend an expansion of the study to demonstrate statistical significance on PFS. On the back of two successful licensing deals, securing a path to the market should now be able to continue unhindered. We have raised our fair value to SEK14–28 (SEK10–23).

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Isofol Medical Licensing deal for Canada

Isofol Medical today announced it has entered into a licensing agreement with Paladin Labs for the commercialisation of arfolitixorin. Isofol is entitled to up to cSEK205m in upfront and milestone payments, and double-digit royalties. However, like the previous deal, the company is tight-lipped about the deal structure. On our valuation, there should be only potential upside to this deal as it incurs no more costs and leaves the door to a global licensing deal open. We have not updated our out-l...

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Isofol Medical Good momentum in Q2

Isofol Medical reported a Q2 operating loss that was slightly better than we expected. The company is fairly well financed after a successful cSEK180m capital raise during Q2. Despite pandemic-related difficulties, Isofol Medical achieved two significant milestones after the quarter. Firstly, 330 patients were recruited in the pivotal phase III study, enabling the interim analysis, with results expected in Q1 2021. Secondly, it announced a licencing deal for the development and commercialisation...

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Isofol Medical Enters into licensing deal for Japan

Isofol Medical today announced it has entered into a licencing agreement with Solasia Pharma for the development and commercialisation of its main asset arfolitixorin in Japan. It will receive cUSD100m in upfront and sales-related payments, with additional double-digit royalties. We view today’s announcement as an important commercial milestone and believe it speaks favourably about management’s ability to deliver despite difficulties relating to Covid-19. We have updated our out-licencing s...

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Isofol Medical Still on track to deliver in Q4

Q1’s operating loss was larger than expected, mainly due to higher R&D spending. The impact from Covid-19 appears limited and management cautiously reiterated timelines. The company plans to strengthen its financial situation through a rights issue that would extend the runway to mid-2021. We believe the gene expression method adds value for Isofol Medical. We have cut our estimated fair value to SEK8–22 (SEK14–42) as a result of the planned increase in share count.

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Isofol Medical Rights issue to secure clinical development

Isofol Medical plans to raise cSEK150m through a fully guaranteed rights issue, with an optional extra SEK30m. Net proceeds will primarily be used to fund the ongoing phase III study. So far the Covid-19 impact on clinical development appears limited. Gene expression data indicates benefits from arfolitixorin in a broader patient population. We reiterate our SEK14–42 fair value.

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Isofol Medical Fully focused on AGENT

Q4’s operating loss was higher than expected, mainly due to continued higher R&D spending as well as costs related to the change of CEO. The 005-study has been concluded and the company’s full attention should now be on bringing arfolitixorin to market. We estimate continued high R&D spending going forward as more sites are expected to be opened. We have tweaked our estimated fair value to SEK14–42 (SEK18–49).

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Isofol Medical Update on clinical development

Isofol Medical yesterday gave an update on several of its clinical programmes. The AGENT study has randomised 200+ patients and is rapidly approaching interim analysis in Q4 2020e. The company also reported the phase I/IIa study ISC-CC-005 had been concluded and a gene expression analysis method had been validated. We reiterate our SEK18–49 fair value.

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Isofol Medical New CEO but goal remains the same

The chairman of the board has been appointed as the new CEO of Isofol Medical, but we do not anticipate any major strategic overhaul. The ongoing pivotal phase III study AGENT continues to progress according to plan and is preparing to include patients in Japan and Australia. An interim read-out from the study is due in mid-2020. The company reported a Q3 operating loss of cSEK46m, fairly in line with our estimate. We reiterate our fair value of SEK18–49/share.