Annual Report, October 25, 2018

Dear Shareholders and Readers

Insulin was discovered in 1921, a discovery that has since saved the lives of millions of people with type 1 and type 2 diabetes around the world. Today, almost 100 years after this pioneering discovery, and despite major progress in new insulin technologies and technical aids, fatality statistics are still anything but encouraging.

In Sweden, where we have access to the best possible diabetes care, life expectancy for children diagnosed with type 1 diabetes before the age of 10 is on average 18 years shorter for girls and 14 years shorter for boys. New improved types of insulin and technical aids are easing everyday life for patients but do not help to solve the problem. Diamyd Medical is working hard to reduce fatalities from type 1 diabetes by developing a drug to save and increase the body’s endogenous insulin production. We have made significant progress in the past fiscal year.

In November 2017, enrollment began to our Phase IIb trial DIAGNODE-2 that will use the diabetes vaccine Diamyd® in recently diagnosed type 1 diabetes. The trial is Diamyd Medical’s largest project for many years and is taking place at clinics in Sweden, Spain and the Czech Republic. The aim of the trial is to verify the positive results regarding preserved endogenous insulin production and better blood glucose control as we last reported in September from the open pilot study DIAGNODE-1. Diamyd® is administered intralymphatically in only three separate injections as an antigen-specific immunotherapy to retrain the body’s immune system safely and specifically - one of the company’s patent-pending technologies, which could become a pillar in the treatment of type 1 diabetes and other autoimmune diseases. There is substantial interest in the trial, facilitating enrollment, which has progressed well and is now in the final stages.

Alongside of this, we are active in our other drug project Remygen®. The ReGenerate-1 trial, which is being conducted together with Uppsala University, began this autumn and is the first clinical trial of our patent-pending oral GABA-based study drug Remygen®. ReGenerate-1 is a Phase I/II trial to study the pharmacokinetic characteristics and safety of Remygen® in individuals who have had type 1 diabetes for longer than five years and to assess the effect of Remygen® in stimulating growth of insulin-producing cells. In parallel, a trial is taking place in the US, at the University of Alabama at Birmingham, of GABA/Diamyd® that was fully enrolled in July 2018. If we can identify increased insulin production in ReGenerate-1 and/or in the GABA/Diamyd® trial, we have then created a foundation for a completely new, regenerative treatment for both type 1 and type 2 diabetes!

Both Diamyd® and Remygen® are at an exciting stage with an opportunity to reach the market faster than would otherwise be expected for drugs at the same development phase. Diamyd® has demonstrated a very good safety profile in trials of more than 1,000 patients and in trials where participants were monitored for up to five years. Remygen® , in turn, is based on a known substance (GABA) and therefore follows a registration procedure requiring less data than for a new, less well-known substance, to fulfil criteria for submitting an application for regulatory approval.
To summarize, we can again note the very large and unfulfilled demand for treatments that can reduce fatalities and complications with type 1 diabetes and our ambition with Diamyd® is to apply for conditional market approval following the results of DIAGNODE-2. The plan for Remygen® is to prepare a trial that would qualify for registration following the results of ReGenerate-1 and GABA/Diamyd® in Alabama.

I also note that our holdings in NextCell Pharma and Companion Medical appear to be developing well. NextCell Pharma, with Diamyd Medical as its largest shareholder, is conducting a clinical trial of its stem-cell-based drug ProTrans in type 1 diabetes and recently expanded its stem-cell saving activities from afterbirth into Denmark. Companion Medical began a limited market launch of its smart insulin pen in the US and received CE conformity marking in Europe. We are following the progress of the two companies with interest.

With two study drugs in the clinical phase, several clinical trials ongoing and positive results behind us, I am highly optimistic and look forward to a very eventful fiscal year.

Stockholm, October 24, 2018
Ulf Hannelius
President and CEO, Diamyd Medical AB (publ)

Both Diamyd® and Remygen® are at an exciting stage with an opportunity to reach the market faster than would otherwise be expected for drugs at the same development phase.
Ulf Hannelius, President and CEO

Annual Report

  October 25, 2018