Quarterly Report I 11/12
Quarterly Report Diamyd Medical AB (publ), fiscal year 2011/2012
(www.omxgroup.com ticker: DIAM B; www.otcqx.com ticker: DMYDY)
Reporting period September 1, 2011 – November 30, 2011
- Group total net sales amounted to MSEK 0.1 (144.5)
- Profit before tax amounted to MSEK -7.4 (98.3)
- Earnings per share after dilution were SEK -0.26 (3.32)
- The Group’s liquid assets amounted to MSEK 414 (478) as of November 30,
2011
Significant events during the reporting period
- Diamyd Medical was awarded a USD three million grant and expanded the NTDDS
portfolio
- University of Florida Research Foundation and Diamyd Medical settled
lawsuit
Significant events after the reporting period
- Prevention study with Diamyd Medical´s diabetes vaccine was fully
recruited
CEO COMMENTS
2012 will be an exciting and significant year for Diamyd Medical. We now have
only a handful of subjects left to enroll in our US Phase II study in cancer
pain with the drug candidate NP2 Enkephalin. Work is underway to ensure the
quality of data and to prepare everything so that we will be able to obtain the
results as quickly as possible after the last patient has been included in the
study. Our prognosis to be able to present results from the study some time
during the first half of 2012 remains unchanged. The results are important to
Diamyd Medical, as it is the first time a drug candidate from the Company’s
NTDDS platform is tested in a larger patient population. Sustained pain relief
was achieved in a smaller, non-placebo-controlled, Phase I study with NP2
Enkephalin. That study included ten subjects with cancer pain. No serious
treatment-related adverse events were observed in that study.
With positive results from the Phase II study, we will be ready to actively seek
partners for the further development of NP2 Enkephalin and other applications of
the NTDDS platform and to start clinical trials with the next drug candidate
from the platform, NG2 GAD. We have good prospects given our financial resources
and our streamlined organization with valuable experience from both clinical
development and from concluding significant partnership agreements with large
pharmaceutical companies.
NTDDS stands for Nerve Targeting Drug Delivery System which is an innovative
technology that enables delivery of therapeutics directly to the nervous system.
The purpose is to achieve a local effect in the cells where the treatment is
targeted without affecting the rest of the body. It is a unique concept that, if
it proves successful, may provide new opportunities to address various medical
problems of the nervous system which today cannot be adequately treated, such as
chronic pain, neuropathy, cancer and neurodegenerative diseases.
The Annual General Meeting was held in December and we can now put the turbulent
2011 behind us and put all our focus on the future. A few weeks before the
meeting, we reached an agreement with the University of Florida and could
thereby settle the dispute with them. We started the new year with the good news
that the Swedish prevention study with the Diamyd® diabetes vaccine had
recruited its fiftieth and final subject. The study aims to prevent type 1
diabetes in children who are at high risk of developing the disease, and it will
be very interesting to follow the coming few years.
Our measures to reduce costs have certainly had an impact during the reporting
period. We are now down to one third of the costs compared to the same period
last year. The Company's cash position with around SEK 400 million,
corresponding to approximately SEK 14 per share, means that the financing of the
existing business is secured and also provides the Company with strategic
leeway. The newly elected board has continued the active strategy work which was
initiated last year and is continuously evaluating different scenarios. The
results from the Phase II study with NP2 Enkephalin will of course affect the
Company's strategic choices going forward, but we will be well prepared
regardless the outcome of the study.
Stockholm, January 25, 2012
Peter Zerhouni
President and CEO Diamyd Medical AB
SIGNIFICANT EVENTS DURING THE REPORTING PERIOD
SEPTEMBER 1, 2011 – NOVEMBER 30, 2011
Diamyd Medical was awarded a USD three million grant and expanded the NTDDS
portfolio. Diamyd Medical with collaborators received a USD three million grant
from the US National Institutes of Health to develop the Company’s patented
Nerve Targeting Drug Delivery System (NTDDS) for prevention of Chemotherapy
Induced Peripheral Neuropathy. The grant allows Diamyd Medical to expand the
NTDDS technology to also target neuropathy, in addition to the Company’s
development portfolio for the treatment of pain.
University of Florida Research Foundation and Diamyd Medical settled lawsuit.
University of Florida Research Foundation, Incorporated ("UFRF"), and Diamyd
Medical AB jointly announced that they have settled the breach of contract
litigation that UFRF filed in the United States Federal District Court in
Florida against Diamyd Medical in January 2011. The dispute related to an
exclusive license agreement between UFRF and Diamyd Medical, and to a sublicense
of the rights under the exclusive license agreement between Diamyd Medical and
Ortho-McNeil-Janssen Pharmaceuticals, Inc., which sublicense involved rights to
the GAD65-based drug candidate Diamyd®. The settlement amount was in line with
what Diamyd Medical had reserved in its accounts as per August 31, 2011
regarding litigation claims.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
Prevention study with Diamyd Medical´s diabetes vaccine was fully recruited. A
total of 50 children aged four and older with a high risk of developing type 1
diabetes have been enrolled in a researcher-initiated Phase II study,
DiAPREV-IT, with Diamyd Medical’s diabetes vaccine Diamyd®. The study is thus
fully recruited. The purpose of the study is to evaluate whether preventive
treatment with Diamyd® can delay or halt the progression of the disease so that
the children do not develop clinical symptoms of type 1 diabetes. The first
results are expected to be compiled three years after the last participant is
enrolled, and can thereby be presented in 2015.
*** 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
Phone: 46 8 661 00 26
