Financial Statement, October 2016

Dear Shareholders

We have now closed the books on an intensive and exciting fiscal year – a year in which my role as the new CEO of Diamyd Medical was characterized by a focus on strategy and business development. My goal has been to further strengthen the company’s licensing possibilities and thus the core of our business model.

So what have we accomplished during the year and how will the results of this work benefit you as a shareholder? To achieve the goal of strengthening our licensing offering, we focused on three stages: 1) evaluating our existing assets, 2) developing the most promising of these assets, and 3) marketing these assets through active participation in conferences and partnering events.

Our flagship project is the diabetes vaccine Diamyd®, where we currently have six ongoing Phase II trials focused on preventing or curing autoimmune diabetes. Combination studies have continued to attract growing interest, a trend that was particularly noticeable at the largest diabetes conference of the year: the 76th American Diabetes Association (ADA) Scientific Sessions. Opinion makers in the field clearly advocate studies that are in line with Diamyd Medical’s development strategy and the scientific basis for our clinical work on antigen-specific immunotherapy – most recently in an article published only a week ago in the scientific journal Diabetologia. In this article, a team of highly respected researchers in the area of type 1 diabetes demonstrate in a comprehensive analysis that the probability of the diabetes vaccine yielding a positive biological effect is very high. The preliminary results of ongoing studies during the fiscal year also demonstrated the feasibility of administering our vaccine directly into the lymph nodes – a patent-pending concept that we look forward with great interest to evaluating on a larger scale and in further detail.

We have clearly advanced our positions with respect to GABA, which has shown excellent potential to be developed into an attractive pharmaceutical for the treatment of diabetes and other inflammatory disorders. In other positive news, after a long period of negotiation, we were finally able to sign an agreement with JDRF, Janssen R&D and the University of Alabama concerning the ongoing GABA/Diamyd® study in Birmingham, Alabama. According to the agreement, resources will be provided to increase the number of patients enrolled in the GABA arm of the study and to analyze additional GABA-related biomarkers. The interest shown by the major players and opinion makers and the research showing the potential of GABA formed the basis for the recently announced expansion of our operations to include a proprietary GABA drug product. Our current focus on autoimmune diabetes is now being expanded to include type 2 diabetes and rheumatoid arthritis, where there is a significant need for better, safer drugs and intensifying competition for market shares among pharmaceutical giants. For Diamyd Medical, this means even greater interest in our offering.

Several milestones will be achieved during the coming year, including the final results from two ongoing Phase II trials with the diabetes vaccine Diamyd® during the first half of 2017 and preliminary results from ongoing open studies. Diamyd Medical will be represented at the most important conferences and partnering events, and the exciting expansion and introduction of a proprietary GABA drug product will attract greater news coverage and interest from potential partners. We are now entering the new fiscal year with a great sense of excitement and confidence, and I would like to thank you, our shareholders, for your continued trust.

Stockholm, October 12, 2016
Ulf Hannelius
President and CEO, Diamyd Medical AB (publ)

Opinion makers in the field clearly advocate studies that are in line with Diamyd Medical’s development strategy.
Ulf Hannelius, President and CEO

Annual Report

  November 05, 2015