Diamyd Medical: Quarterly Report I 12/13

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Quarterly Report 1, Diamyd Medical AB (publ) (STO:DIAMB)(Pink Sheets:DMYDY), fiscal year 2012/2013

Reporting period September 1, 2012 – November 30, 2012

  • Group net sales amounted to MSEK 0 (0.2)
  • Loss before tax amounted to MSEK -1.8 (-3.5)
  • Earnings per share after dilution were SEK -0.2 (-0.3)
  • Liquid assets and short term investments amounted to MSEK 373 (414) as of November 30, 2012

Significant events during the reporting period

  • Agreement was entered into for the sale of US gene therapy company and an Extraordinary General Meeting of Diamyd Medical AB approved the sale
  • Diamyd Medical limited further investment in the diabetes vaccine Diamyd®

Significant events after the reporting period

  • New Board members of Diamyd Medical AB
  • The Board’s proposal regarding redemption of shares and stock dividend, and an alternative shareholder proposal, were announced
  • Recombinant vaccine from Protein Sciences received FDA approval

CEO COMMENTS

We recently got the good news that Protein Sciences has received market approval for their influenza vaccine FluBlok in the US. It has taken a long time and they have overcome many hurdles along the way, but it is an inspiring example of that perseverance pays. The approval has received a lot of attention in the US. Protein Sciences is planning to have a limited launch of the product in February 2013 with the full launch occurring in time for the 2013/14 influenza season. Diamyd Medical holds about 8 percent of the shares in Protein Sciences.

Flublok is the first vaccine against seasonal influenza that is manufactured using modern recombinant technology to reach the US market. The advantages compared to traditional vaccine manufacturing are that it requires less lead time to manufacture after the identification of the year's flu strains, the vaccines are not produced in eggs and therefore do not contain egg derivatives, and the manufacturing does not require the use of live influenza virus, the mercury compound thimerosal or antibiotics. Protein Sciences is also developing a similar vaccine against pandemic influenza in collaboration with the Biomedical Advanced Research and Development Authority, a division of the US Department of Health and Human Services.

We see a continued strong interest from researchers in our own diabetes vaccine Diamyd®. Our plan is to encourage researcher initiated studies, where Diamyd® is tested in combination with other drugs, in limited, less costly clinical pilot studies in recent-onset type 1 diabetes. By attacking the disease from several sides with combination therapy, the idea is to provide a better chance for the diabetes vaccine to intervene in the autoimmune disease process underlying type 1 diabetes. We also want to see more researcher initiated studies started to test the diabetes vaccine in people who have not yet developed type 1 diabetes, but are demonstrated to have an elevated risk of developing the disease. There is already such a pilot study ongoing in Sweden, where results are expected in 2015. By collaborating with externally funded research groups, we will be able to test more treatment paradigms than if we would have conducted and funded all the studies ourselves.

On January 31, we have an Extraordinary General Meeting in Stockholm. The meeting will resolve on the distribution of SEK 118 million, corresponding to about a third of the Company’s cash, to our shareholders through a share redemption program. If the meeting resolves on the redemption of shares, the shareholders will receive detailed information on the redemption procedure.

Stockholm, January 23, 2013

Peter Zerhouni President and CEO Diamyd Medical AB

Note: Historical comparative figures in the report are presented excluding Diamyd, Inc. and the NTDDS operations, which were divested during the autumn of 2012.

SIGNIFICANT EVENTS DURING THE REPORTING PERIOD SEPTEMBER 1, 2012 – NOVEMBER 30, 2012

Agreement was entered into for the sale of US gene therapy company and an Extraordinary General Meeting of Diamyd Medical AB approved the sale. Diamyd Medical AB entered into an agreement for the sale of the US subsidiary, Diamyd, Inc., involved in drug development primarily relating to the NTDDS platform with applications in pain and neuropathy among others. The buyer, Periphagen Holdings, Inc., is owned by members of the management of Diamyd, Inc. The agreement was subject to approval of an Extraordinary General Meeting of Diamyd Medical. By reason of the divestment, Diamyd Medical postponed its Year End Report to October 31, 2012. An Extraordinary General Meeting of Diamyd Medical AB held on October 30, 2012, decided in accordance with the Board's resolution, to approve the agreement to sell all shares in the subsidiary, Diamyd, Inc. to Periphagen Holdings, Inc.

Diamyd Medical limited further investment in the diabetes vaccine Diamyd®. Diamyd Medical AB decided to allocate a maximum of SEK 30 million over three years for the development of the diabetes vaccine Diamyd®. The development activities are gathered in the subsidiary Diamyd Therapeutics.

SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD

New Board members of Diamyd Medical AB. At the Annual General Meeting of Diamyd Medical AB on December 6, 2012, Erik Nerpin and Jonas Jendi were elected as new Board members. Anders Essen-Möller was re-elected as Chairman of the Board and Maria-Teresa Essen-Möller was re-elected to the Board. The former Board members Lars Jonsson, Joseph Janes and Christer Lindberg declined re-election.

The Board’s proposal regarding redemption of shares and stock dividend, and an alternative shareholder proposal, were announced. Diamyd Medical AB announced the Board’s complete proposal regarding redemption of shares and stock dividend, including the Board’s and the auditors' opinions and statements under the Companies Act, to be considered at an Extraordinary General Meeting on January 31, 2013. Furthermore, an alternative proposal for the structure of the redemption procedure by the shareholder Bertil Lindkvist was also announced.

Recombinant vaccine from Protein Sciences received FDA approval. The US Food and Drug Administration approved Protein Sciences Corporation’s vaccine Flublok for the prevention of seasonal influenza in adults 18 to 49 years of age. Diamyd Medical holds about 8 percent of the shares in Protein Sciences Corporation.

*** To read the complete report, please follow the link to the PDF: http://mb.cision.com/Main/566/9359939/84573.pdf or visit www.diamyd.com ***

Diamyd Medical AB (publ), Karlavägen 108, SE-115 26 Stockholm, Sweden. Phone: +46 8 661 00 26 Fax: +46 8 661 63 68. E-mail: info@diamyd.com. Reg. no: 556530-1420

This information is disclosed in accordance with the Swedish Securities Markets Act, the Swedish Financial Instruments Trading Act, or the requirements stated in the listing agreements.

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Contacts

Diamyd Medical AB
Peter Zerhouni
President and CEO
Phone: + 46 8 661 00 26
Fax: +46 8 661 63 68
E-mail: info@diamyd.com

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Contacts

Diamyd Medical AB
Peter Zerhouni
President and CEO
Phone: + 46 8 661 00 26
Fax: +46 8 661 63 68
E-mail: info@diamyd.com