Quarterly Report 1, January 23, 2019

Dear Shareholders and Readers

I am pleased to report significant clinical, strategic and financial progress for this quarter. In November we reported that 11 out of 12 patients treated with intralymphatic Diamyd® in the DIAGNODE-1 trial are in partial remission about 18 months after diagnosis of type 1 diabetes. This is notable as partial remission, defined as the patient having a well-controlled blood sugar level and a low requirement for external insulin, is seen in patients that have had the disease for more than a year. The fact that retained endogenous insulin production, lower blood sugar levels AND lower insulin requirements can be seen, is very attractive. Importantly, and as highlighted during several recent partnering meetings, this efficacy profile clearly satisfies the commercial requirements set by larger pharmaceutical companies. From a competitive standpoint it should be mentioned that very few candidate compounds that have been evaluated in clinical trials have achieved similar indications of effect, while our antigen specific Diamyd® therapeutic points at both superior safety profile and patient convenience (three injections only).

We are enormously proud that Professor Mark Atkinson, one of the world's most respected type 1 diabetes researchers and key opinion leaders agreed to join our Board of Directors in November. Mark is actively contributing with his expertise and joined us for several important meetings with potential partners recently during the JP Morgan Healthcare week in San Francisco.

We are confident in the Diamyd® program, and Mark is adept at highlighting the unique strengths of the program while also providing increased international visibility to our company.

Our cash position was strengthened through the redemption of warrants in November. The raised SEK 58 million means that the ongoing DIAGNODE-2 trial is fully financed until results in the third quarter of 2020.

Our top strategic priority during this financial year is to prepare for a marketing application for Diamyd®. These regulatory activities are performed in parallel with the ongoing clinical program, with the aim to file by the end of 2020 together with one or a few strategic partners, in order to maximize the potential in the program as well as the shareholder value.

With several upcoming milestones including full recruitment of DIAGNODE-2, results from booster injections in DIAGNODE-1 and our GABA program with the ongoing ReGenerate-1 trial in Uppsala, we have an exciting period ahead.

Stockholm, January 23, 2019
Ulf Hannelius
President and CEO, Diamyd Medical AB (publ)

Our top strategic priority is to prepare for a marketing application for Diamyd®.
Ulf Hannelius, President and CEO

Annual Report

  October 25, 2018