September 2012 - August 2013 Diamyd Medical AB (publ), former Diamyd Therapeutics AB Fiscal year 2012/2013

Reporting period, June 1, 2013 - August 31, 2013

  • Net sales amounted to MSEK 0.1 (0)
  • Loss before tax amounted to MSEK -4.3 (-4.2)
  • Liquid assets amounted to MSEK 65.5 (22.0) as of August 31, 2013

Full year, September 1, 2012 - August 31, 2013

  • Net sales amounted to MSEK 0.1 (0.5)
  • Loss before tax amounted to MSEK -12.6 (-16.3)

Significant events during the reporting period
June 1, 2013 - August 31, 2013

  • Diamyd Medical's rights issue was oversubscribed and raised
    approximately MSEK 21
  • Diamyd Medical expanded its Scientific Advisory Board

Significant events after the reporting period

  • Major owner increased holdings in Diamyd Medical

CEO Comments

After an intense period in May and June with the listing on First North, and an oversubscribed rights issue, Diamyd Medical's focus has shifted to business development activities and the production of a new batch of the diabetes vaccine Diamyd®. Our current inventory needs to be renewed and the manufacturing process has evolved since we last made a batch for clinical use.

Having sufficient inventory of fresh diabetes vaccine available is vital for our strategy of collaborating with externally funded research groups to establish additional clinical pilot studies with Diamyd®. Both in combination with other drugs to achieve a strong beta cell preserving effect, and by treating earlier in the disease process to try to prevent the onset of type 1 diabetes and other autoimmune diabetes altogether.

Manufacturing of the new batch was carried out late September in the Netherlands and was completed without problems. Pharmaceutical manufacturing is subject to a strict regulatory framework called Good Manufacturing Practice (GMP), which sets high quality standards. Currently a wide range of tests are performed on the product to confirm that it meets all manufacturing specifications. We expect that the new vials with the diabetes vaccine Diamyd®will be released for use in clinical trials later this autumn.

We work in parallel with several academic research groups who have ideas for new studies with the diabetes vaccine. The advantage of this approach is that we can test more hypotheses than if we were to conduct and fund all studies with the diabetes vaccine ourselves. The downside compared to company-funded studies, is that it takes more time since we are dependent upon the scientists actively working on the projects and seeking and receiving grants, at the same time as they are busy with their regular work at their respective hospitals.

Two researcher-initiated studies with Diamyd®are already in progress. The study DIABGAD-1 evaluates treatment with the diabetes vaccine in combination with the anti-inflammatory drug ibuprofen and relatively high doses of vitamin D. The study was launched earlier this year and more than a third of the planned 60 patients have been enrolled. Also, since 2009 a researcher-initiated study is in progress with children at high risk of developing type 1 diabetes, with the aim to prevent the onset of the disease.

Regarding business development, we are working hard to evaluate new opportunities for collaboration and deals in the field of diabetes. We have participated in several international diabetes meetings and will also be represented at the annual ISPAD Meeting (International Society for Pediatric and Adolescent Diabetes) next week, which this year will take place in Gothenburg. Also next week, at the Nordic Life Science Days in Stockholm, we will present Diamyd Medical to potential investors and partners from around the world.

Stockholm, October 10, 2013

Peter Zerhouni
President and CEO Diamyd Medical AB (publ)

Significant events during the reporting period
June 1, 2013 - August 31, 2013

Diamyd Medical's rights issue was oversubscribed and raised approximately MSEK 21
Diamyd Medical's share issue with preferential rights for the Company's shareholders was oversubscribed. The Company received proceeds of MSEK 20.7 before issue expenses.

Diamyd Medical expanded its Scientific Advisory Board
The Company's Scientific and Medical Advisory Board was expanded with three internationally leading experts on GABA and diabetes: Dr. Bryndis Birnir at Uppsala University, Dr. Brooke Ligon and Dr. Qinghua Wang at Toronto University.


Significant events after the reporting period

Major owner increased holdings in Diamyd Medical
Bertil Lindkvist increased his holdings in Diamyd Medical. Bertil Lindkvist's holdings in Diamyd Medical amounted to 2,979,286 B-shares as of September 24, 2013, which corresponds to 15.1 percent of the capital and 10.5 percent of the votes.

*** To read the complete report, please see attached pdf, or visit www.diamyd.com ***

For more information please contact:
Peter Zerhouni, President and CEO Diamyd Medical AB (publ). Phone: +46 8 661 00 26

Diamyd Medical AB (publ), Kungsgatan 29, SE-111 56 Stockholm, Sweden
Phone: +46 8 661 00 26  Fax: +46 8 661 63 68  E-mail: info@diamyd.com  Reg no: 556242-3797

Note: This document has been prepared in both Swedish and English. The Swedish version shall govern in case of differences between the two documents. The document contains certain statements about the Company's operating environment and future performance.

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