Financial Statement, October 11, 2017

Dear Shareholders and Readers

Given the strategic decisions taken over the past year and the company’s strong cash position following the successful new share issue this spring, we have significantly accelerated our operations during the quarter.

During the quarter national competent authorities from all of the participating countries (Spain, Sweden and Czech Republic) approved the conduction of the DIAGNODE-2 trial. The Investigator Meeting we arranged last week in Barcelona, at which the trial protocol was presented and discussed, was well attended and appreciated. The enthusiasm for the upcoming trial is high and stems from the promising preliminary results from the ongoing open DIAGNODE-1 trial, where Diamyd® is administered directly into the lymph node. After the decision was taken in the spring to conduct our own follow-up trial, our organization has in collaboration with our partners and contract manufacturers made an ambitious achievement moving the project forward on an aggressive timeline with a focus on starting as early as possible and efficient patient recruitment.

During the quarter we have also reached another milestone. We have established the formulation of our GABA study drug, filed a patent application on the formulation, and named it Remygen®. Manufacturing according to GMP (Good Manufacturing Process) has been validated and various pilot formulations were evaluated during the summer both at test-tube level and in a pharmacokinetic study. Remygen® is based on one of these formulations with specific desirable properties in terms of release and uptake. A consultative meeting regarding Remygen® and clinical trials was held with the Medical Products Agency in September and the first clinical trial will focus on beta cell growth in a selected population of type 1 diabetes patients. The ongoing GABA and Diamyd® trial at the University of Alabama at Birmingham focusing on recently diagnosed type 1 diabetes is progressing as planned with 74 of the 95 participants now enrolled and 41 having completed the trial.

On the business front, we are pursuing two courses of action. With the diabetes vaccine Diamyd® the Company is aiming to enter into licensing agreements for intralymphatic administration with the possibility of option agreements before the results from DIAGNODE-2 and for Remygen® to enter into licensing agreements or collaboration agreements. During the quarter, we participated at the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) conferences, the two largest diabetes conferences in the US and Europe, as well as at the Nordic Life Science Days in Sweden. These conferences continue to devote greater attention to type 1 diabetes and the field is open to new treatment possibilities that apply lessons learned from the treatment of, inter alia, rheumatoid arthritis and other autoimmune diseases, for which a number of drugs are currently being marketed. With the preliminary results from DIAGNODE-1 and the impending start of DIAGNODE-2, we have an attractive package to offer our potential partners. In conjunction with the above, additional recombinant GAD was ordered toward the tail-end of summer from our US contract manufacturer.

Stockholm, October 11, 2017
Ulf Hannelius
President and CEO, Diamyd Medical AB (publ)

We have made an ambitious achievement moving the DIAGNODE-2 trial forward on an aggressive timeline.
Ulf Hannelius, President and CEO

Annual Report

  November 3, 2016