Quarterly Report 2, April 2016

Dear Shareholders

The second quarter of this fiscal year and the period thereafter have been exciting and eventful. We presented preliminary reports from three different ongoing combination studies with the diabetes vaccine Diamyd®: 1) DIABGAD (Diamyd®/ibuprofen/vitamin D); 2) DIAGNODE (intralymphatic injection of Diamyd®/vitamin D); 3) EDCR (Diamyd®/etanercept/vitamin D), and all have shown a good safety profile thus far. We applied for and, after the end of the period, received approval from both the Swedish Medical Products Agency and the Ethics Review Board for a certain extension of the DIAGNODE trial, and we are engaged in discussions regarding an extension of the GABA/Diamyd® trial in Birmingham/Alabama. An agreement was signed with Uppsala University Hospital to conduct a new investigator-initiated trial with the combination of GABA/Diamyd®, however, the trial startup is pending discussions with the Medical Products Agency and necessary subsequent approvals.

Cellaviva AB, which is now in business saving stem cells from umbilical cords, and in which we have a shareholding of about 45%, is currently conducting a bridge financing and has appointed the undersigned as Chairman. According to many experts, stem cells may revolutionize regenerative and immunomodulatory therapies for autoimmune, neurological, metabolic, and cardiovascular diseases, as well as cumulative trauma disorders. Pending evidence for this, so that public funds possibly may be earmarked for family saving of umbilical cord stem cells, perhaps primarily for children in risk groups – such as the children of parents with diabetes or other autoimmune or genetic risk predispositions – it may be important for Sweden’s future position within the pharmaceutical industry, that such industry closely cooperates with pharmaceutical research in joint development efforts. Cellaviva’s early adopters – i.e. its customers – can therefore be described as breaking new ground for future, not-yet fully identified, medical applications for own (autologous) stem cells. Diamyd Medical’s prime interest is to find ways to differentiate umbilical cord stem cells into insulin-producing beta cells, and we have now initiated an international application for funding of such research. We have also conducted a field trip to one of the world’s leading umbilical cord blood banks in Los Angeles.

Together with a representative from Eli Lilly, we also visited our “8% shareholding” in San Diego, Companion Medical Inc., which is developing a smart pen for insulin administration, and we are pleased to report that a 510(k) Premarket Notification as well as a CE-mark application for clearance to sell smart insulin pens in Europe have been submitted. However, no forecast or timeframe for these applications are given.

Finally, a rights issue was implemented, which was over-subscribed to 207 percent and generated MSEK 22 to Diamyd Medical. At today’s date, our cash funds therefore amount to approximately MSEK 40.

As previously reported, the plan for our world-leading Antigen Based Therapy for type 1 diabetes, is to evaluate the diabetes vaccine Diamyd®– which has shown a good safety profile in trials with more than 1,000 patients – together with various other compounds to receive guidance on which treatment regimen that is best able to enhance the effect (16%, p=0.1) that was achieved in a previous European Phase III trial. We aim to cure type 1 diabetes by first inducing immunological tolerance to the insulin-producing beta cells and then restore the functional beta cell mass by stem cell therapy.

We are moving forward according to plan. To create value for you, our shareholders, and for you, with type 1 diabetes.

Stockholm, April 6, 2016
Anders Essen-Möller
President and CEO Diamyd Medical AB (publ)


We aim to cure type 1 diabetes by first inducing immunological tolerance to the insulin-producing beta cells and then restore the functional beta cell mass by stem cell therapy.
Anders Essen-Möller, President and CEO

Annual Report

  November 05, 2015