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
About Diamyd Medical
Diamyd Medical is a Swedish biotech company focusing on the
development of pharmaceuticals for the treatment of pain,
neuropathy and diabetes. The portfolio of development
projects for the treatment of chronic pain and neuropathy
uses the Company's patented NTDDS (Nerve Targeting Drug
Delivery System) platform to administer therapeutic agents
directly to the nervous system. The development project
within the area of diabetes consists of the protein GAD65 for
the treatment and prevention of autoimmune diabetes.
Diamyd Medical has offices in Sweden and in the US. Shares
are listed on Nasdaq OMX (segment Small Cap) in Stockholm
(ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY)
administered by the Pink OTC Markets and the Bank of New York
Mellon (PAL). Further information is available on the
Company's website: www.diamyd.com.
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.
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
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