Reporting period March 1, 2014 – May 31, 2014
- Net sales amounted to MSEK 0 (0)
- Loss before tax amounted to MSEK -3.6 (-4.0)
- Liquid assets and short term investments amounted
to MSEK 39 (48) as of May 31, 2014
First nine months, September 1, 2013 – May 31, 2014
- Net sales amounted to MSEK 0.3 (0)
- Loss before tax amounted to MSEK -12.8 (-8.3)
Significant events during the reporting period
- Diamyd Medical’s former sister company Periphagen, Inc. (former Diamyd, Inc.) secured new financing
- Diamyd Medical entered the stem cell field with investment in Swedish cord blood bank
- Diamyd Medical invested in a US medical device company
Significant events after the reporting period
- Clinical study with Diamyd Medical’s diabetes vaccine fully recruited
CEO comments
At the beginning of June, the final participants were included in the researcher-initiated study DIABGAD-1 following intensive and successful recruitment efforts. Slightly more than 60 children and adolescents with newly diagnosed type 1 diabetes are participating in the study and testing our diabetes vaccine, Diamyd®, in a unique combination with vitamin D and ibuprofen. We strongly believe in attacking the disease process in type 1 diabetes from several angles simultaneously by combining Diamyd® with other drugs and this is one of the first such studies anywhere in the world. The Phase II study will also evaluate the effect of a double dose of Diamyd®. The aim of the treatment is to preserve the patients’ endogenous insulin production. Now that the last participant has been treated, we know that the first planned analysis focusing on immunological markers can be initiated at the end of 2014 and, accordingly, the results presented at the start of 2015.
The study is being led by Professor Johnny Ludvigsson at Linköping University. Professor Ludvigsson is ranked as one of the world’s ten most distinguished researchers of type 1 diabetes according to a recent analysis based on scientific publications in the field over the last ten years. Professor Mark Atkinson, who is a member of Diamyd Medical’s Scientific Advisory Board, is found at second place in the top-ten list and Diamyd Medical also collaborates with several other top names. The list was published in June at the annual US diabetes conference that was held in San Francisco and which brought together over 17,000 participants. As usual, Diamyd Medical was there to network and to discuss possibilities for future collaborations.
At the same time, there is an ongoing researcher-initiated pilot study with Diamyd®, called DiAPREV-IT, which is testing whether the diabetes vaccine can prevent or delay type 1 diabetes in healthy children who are at high risk of developing the disease. Simply delaying the onset of the disease with the help of the diabetes vaccine would be a major medical success. The pilot study currently comprises 50 children aged four and upwards and the research team at Lund University conducting DiAPREV-IT would like to test the concept on more children to increase the probability of being able to demonstrate a statistically significant preventive effect of the diabetes vaccine. The research team is in discussions with the Swedish Medical Products Agency and Diamyd Medical about the most appropriate way of increasing the sample size by means of additional children.
Efforts continue to launch additional researcher-initiated clinical trials with Diamyd® and we have well-advanced plans in place with several teams of researchers.
In April, we invested in two exciting startups. The first and largest investment was in Sweden’s first commercial stem cell bank for private family saving of umbilical cord blood and other sources of stem cells. Diamyd procured a 46-percent holding for an investment of MSEK 11.5. The company has taken the name Cellaviva and is in the process of establishing its operations in close proximity to Karolinska Institutet's cell therapy and regenerative medicine programs.
The second investment was in Companion Medical, a newly started medical technology company in San Diego, in the US, which develops advanced technical devices for people living with insulin-treated diabetes. For competitive reasons, Companion Medical does not want us to reveal exactly what it is developing, more than that it comprises a cost-effective system combining the best features of existing solutions for delivering insulin to the body together with advanced data management. It was our presence in the global diabetes world that generated the opportunity for us to invest in Companion with its highly skilled and experienced team. In addition to a ten-percent ownership stake, Diamyd Medical also gains the distribution rights for its future products in the Nordic region. The investment makes it possible to broaden our diabetes portfolio in the long term and to enter the medical technology market.
Stockholm, July 2, 2014
Peter Zerhouni
President and CEO Diamyd Medical AB (publ)
Significant events during the reporting period
March 1, 2014 – May 31, 2014
Diamyd Medical’s former sister company secured new financing
Diamyd Medical holds shares in the US gene therapy company Periphagen Holdings, Inc. Periphagen announced the successful completion of a financing transaction where a life science fund invests up to USD 16 million, of which USD 6.5 million has been closed.
Diamyd Medical entered the stem cell field with investment in Swedish cord blood bank
Diamyd Medical signed an agreement with a group of founding partners and Karolinska Institutet Holding AB, by which Diamyd Medical agrees to invest SEK 11.5 million for the establishment of a commercial cord blood bank in Sweden for private family saving of umbilical cord blood and other sources of stem cells. The intention is also to collect and make available stem cells from umbilical cord tissue for research purposes in order to advance the fields of stem cells and regenerative medicine, including research within type 1 diabetes.
Diamyd Medical invested in a US medical device company
Diamyd Medical entered into an agreement to purchase 10 percent of the American start-up med-tech company Companion Medical, Inc. for corresponding approximately SEK 1.6 million. Companion Medical develops advanced technical devices for people living with insulin treated diabetes. Diamyd Medical will have a seat on the Board of Companion Medical as well as the distribution rights to Companion Medical’s future products in the Nordic countries.
Significant events after the reporting period
Clinical study with Diamyd Medical’s diabetes vaccine fully recruited
Diamyd Medical announced that all participants had been included in a Phase II clinical study, DIABGAD-1, in which Diamyd Medical’s diabetes vaccine Diamyd®, in a unique combination with other drugs, is tested in children and adolescents recently diagnosed with type 1 diabetes. The first results from the researcher-initiated study will thereby be available in the beginning of 2015.
*** To read the complete report, please visit www.diamyd.com, or see attached PDF ***