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Immunovia

New opportunities in sight as first sales approach

Update | Pharmaceutical & healthcare | 02 Oct 2017

Immunovia is on track to start commercialising its PanCan-d test for the early detection of pancreatic cancer in high-risk patients in 2018. To this end, it has established its US headquarters in Boston, which includes a laboratory regulated via the Clinical Laboratory Improvement Amendments (CLIA) programme. It has also identified a new important opportunity for the PanCan-d test in the early pancreatic cancer symptoms group, has announced further positive data on the differentiation of autoimmune diseases, and continues the preparations for a retrospective study and a biomarkers study in the diabetic population. Our valuation is SEK157/sh.

Immunovia

Exploring new avenues

Update | Pharmaceutical & healthcare | 06 Sep 2018

Immunovia has announced that it needs to optimise the algorithms used in the IMMray PanCan-d test in high-risk patients due to sample collection-related variability, which will delay the first sales of the product for a year from late 2018 to late 2019. Separately, Immunovia has shown the IMMray platform can differentiate between healthy and lung cancer samples with 95% accuracy. On the autoimmune front, IMMray has proven efficacious in detecting patients with rheumatoid arthritis (RA) who tested negative for antibodies against cyclic citrullinated peptides (CCP) with 90% accuracy, allowing a potential increase of up to 30% in detection rate. Both studies will be validated in further trials. Net cash at end H118 was SEK447.2m. Our updated valuation is SEK3.5bn vs SEK3.6bn before.

Immunovia

IMMray PanCan-d approaches the market

Outlook | Pharmaceutical & healthcare | 22 Mar 2018

Immunovia is preparing to market its IMMray PanCan-d for self-pay patients at high risk of pancreatic cancer (PC) in Q418, after preparatory activities were pushed back slightly from mid-2017 to 2018. To achieve reimbursement, a prospective trial in this population is being run and if positive, the test could be reimbursed in 2020. Immunovia is pursuing other groups ie patients with new-onset T2 diabetes aged 50+ and those with early gastric symptoms. Our revised valuation is SEK3.6bn as we now include early gastric symptoms. Autoimmune diseases represent upside.

Immunovia

Preparing to tackle big markets

Update | Pharmaceutical & healthcare | 07 Dec 2017

Immunovia continues to leverage the IMMray technology to additional opportunities with prospective trials in the group of early pancreatic cancer symptoms (PANSYM-1) due to start in the next few weeks. In diabetes patients (PANDIA-1) trials should start after the readout of a retrospective study in this population expected in Q118. Immunovia is preparing for the launch of a PanCan-d test for the early detection of pancreatic cancer in high-risk patients in 2018. Our valuation is SEK156/share.

Immunovia

Final top-line IMMray data in Lupus, FY16 results

Update | Pharmaceutical & healthcare | 30 Mar 2017

Immunovia has announced final top-line data of the IMMray platform from a retrospective study in autoimmune diseases. The study showed that the IMMray biomarker platform could differentiate blood samples from patients with systemic lupus erythematosus (SLE) from other autoimmune diseases with 96% accuracy. This is an important first step to show the versatility and potential expansion of the IMMray technology to other indications. Immunovia's main focus continues to be pancreatic cancer in high-risk individuals and newly diagnosed diabetic patients. Additionally, the company has reported full year 2016 financial results. Cash at end 2016 was SEK259m; we have updated our valuation to SEK151 per share.

Immunovia

First NCI collaboration in the diabetes opportunity

Update | Pharmaceutical & healthcare | 20 Dec 2016

Immunovia has taken key steps in both opportunities being pursued for its IMMray PanCan-d test for the early detection of pancreatic cancer. In diabetes, a collaboration with the Early Detection Research Network (EDRN), part of the US National Cancer Institute (NCI), is an important step forwards as it could lead to the start of the required clinical study. Diabetes is the larger of the two indications with 3.4 million newly diagnosed diabetes patients every year in the US and EU. In high-risk pancreatic cancer patients, Immunovia has now started a prospective clinical trial, as expected. This is a smaller opportunity (c 200k patients) but could generate initial revenues in 2018. Our valuation remains SEK155.2/share.

Immunovia

Getting the immune system to work in diagnostics

Initiation | Pharmaceutical & healthcare | 10 Nov 2016

Immunovia is ready to validate its test for the early diagnosis of pancreatic cancer from its IMMray platform. Pancreatic cancer is rare and difficult to treat, with a five-year survival rate of c 5%; early diagnosis could improve this to c 50%. This would make an accurate diagnostic test cost-effective in higher-risk patient groups. A prospective trial will start in Q416, with first out-of-pocket sales in 2018 before reimbursement is achieved. Screening of patients newly diagnosed with type 2 diabetes provides additional upside. We value Immunovia at SEK2.6bn or SEK155.2/share.