Semi-Annual Report Stockholm April 29, 2009
Second quarter report for Diamyd Medical AB (publ), fiscal year 2008/2009
(www.omxgroup.com ticker: DIAM B; www.otcqx.com ticker: DMYDY)
December 1 - February 28, 2009
• The FDA approved a combination study of the Diamyd® vaccine with the purpose
of restoring the ability to produce insulin in patients with type 1 diabetes
• A groundbreaking prevention study of the Diamyd® vaccine was approved by the
Norwegian Medicines Agency
• Diamyd Medical received a new approval to follow Swedish children and confirm
the long-term efficacy of Diamyd®
• Diamyd Medical's European Phase III trial was approved in all nine countries
• A pioneering study of the Diamyd® vaccine for the prevention of type 1
diabetes was approved by the Swedish Medical Products Agency (after reporting
period)
• Diamyd Medical licensed a new pain product (after reporting period)
• Subscription of shares upon exercise of subscription warrant DIAM TO 2B from
March 16 to April 17, which provided SEK 28 million in additional capital
(after reporting period)
• Employee Options were granted to Diamyd Medical employees, on April 1 2009,
according to the approval of a new option program (after reporting period)
• Diamyd Medical is discussing the possibility of combining its Phase III
trials (after
reporting period)
• Group net sales for the second quarter were kSEK 778 (682)
• The net loss for the second quarter was kSEK 15,399 (16,541)
• Group liquid assets amounted to kSEK 50,375 (39,253)
• Earnings per share after dilution for the second quarter are SEK -1.4 (-1.7)
September 1, 2008 - February 28, 2009
• Group Net sales for first half of the year were kSEK 866 (831)
• The net loss for the first half of the year was kSEK 25,805 (33,664)
• Earnings per share after dilution for the first half of the year were SEK
-2.4 (-3.4)
CEO OVERVIEW
Treating, preventing and curing diabetes
In the last quarter Diamyd Medical was able to report significant progress in
no less than five different simultaneous trials to evaluate the efficacy of the
Diamyd® vaccine.
Our European Phase III trial has now been approved in all nine countries, an
important milestone which has allowed us to sign up additional clinics in
important countries such as Germany, France and Italy, which have all quickly
begun treating children and adolescents with recent-onset type 1 diabetes. This
means that the trial is fully under way and recruitment of new patients is
proceeding even faster than before.
It's also of great importance to Diamyd Medical's future development that we
received approval from the Swedish Medical Products Agency in mid-January to
continue following the children with type 1 diabetes who were vaccinated with
Diamyd® four years ago. This is a strategically important trial with the
purpose of confirming the long-term efficacy of the Diamyd® vaccine, a trial
we've already begun, and where recruitment is simplified by the fact that the
patients are already identified.
In addition, there were three major news items during the period about new
studies where the efficacy of the Diamyd® vaccine is evaluated by independent
research groups, which removes the financial burden from us, while as a Company
we are entitled to the study results. Two of these news items went worldwide,
at nearly the same time.
On February 13 we were able to report that the Norwegian Medicines Agency had
approved a completely unique prevention study for adults. The purpose of the
study is to study the disease process before type 1 diabetes manifests, while
at the same time the researchers are investigating how the Diamyd® vaccine
reduces the destruction of beta cells and whether treatment with Diamyd® can
prevent the disease. Ten days later, on March 4, we were able to report that
the Swedish Medical Products Agency had approved an additional prevention study
to evaluate the potential of the Diamyd® vaccine to prevent type 1 diabetes
from manifesting in young children at a high risk of developing the disease.
Both of these studies may produce significant and entirely new knowledge, not
only about the Diamyd® vaccine, but also about type 1 diabetes in general. They
may also lead to significantly improved understanding of the mechanisms that
affect the progress of the disease.
We've been able to report positive news from the US, as the FDA approved a
combination study of the Diamyd® vaccine with the purpose of restoring the
ability to produce insulin in patients with type 1 diabetes. The Diamyd®
vaccine is being tested in the study in combination with medication considered
to stimulate the growth of new insulin-producing beta cells. The study is being
financed and conducted by the respected National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK). From a life cycle perspective, the study
means that we are evaluating the vaccine's potential to cure, while
simultaneously pursuing a treatment and prevention strategy.
In addition to the studies that we've reported, I also want to mention in
closing that the TrialNet trial study of the Diamyd® vaccine financed by the
National Institutes of Health has started in the US.
As in the past, our goal is to bring the Diamyd® vaccine to approval globally
in the shortest time and at the lowest cost possible. Our recent successes
demonstrate that we are on the right path, which motivates us to work even
harder to reach the market.
Elisabeth Lindner, President and CEO, Diamyd Medical AB
SIGNIFICANT EVENTS DURING THE PERIOD
The FDA approved a combination study of the Diamyd® vaccine with the purpose of
restoring the ability to produce insulin in patients with type 1 diabetes. The
study means that the Diamyd® vaccine is being tested in combination with
medication considered to stimulate the growth of new insulin-producing beta
cells.
A groundbreaking prevention study of the Diamyd® vaccine was approved by the
Norwegian Medicines Agency. The purpose of the study in Norway is to
investigate the disease process before type 1 diabetes manifests, and whether
treatment with the Diamyd® diabetes vaccine will halt the progress of the
disease.
Diamyd Medical received a new approval to follow Swedish children and confirm
the long-term efficacy of the Diamyd® vaccine. The study means that Diamyd
Medical will continue to follow the 70 children with type 1 diabetes who were
part of the Company's Phase II trial of the Diamyd® vaccine initiated four
years ago for three more years.
Diamyd Medical's European Phase III trial was approved in all nine countries.
The trial includes a total of 320 children in nine countries. Its purpose is to
evaluate the efficacy of the Diamyd® vaccine in preserving the capacity to
produce insulin in children and adolescents with recent-onset type 1 diabetes.
OTHER SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
A pioneering study of the Diamyd® vaccine for the prevention of childhood
diabetes was aproved by the Swedish Medical Products Agency. The purpose of the
study is to evaluate whether the Diamyd® vaccine successfully interrupts the
course of the disease in Swedish children at high risk of developing type 1
diabetes, thus preventing the disease from manifesting.
Diamyd Medical licensed a new pain product. The agreement covers an exclusive
license for a new endomorphin technology which is an important strategic
complement to Diamyd Medical's pain portfolio, which now encompasses all three
primary pain receptors.
Subscription of shares upon exercise of subscription warrant DIAM TO 2B from
March 16 to April 17, 2009. The warrants that accompanied each newly issued
share from the directed placement of spring 2008 were listed for trading on the
market place First North as of June 10, 2008, and were traded through April 8,
2009. The subscription period was from March 16 until April 17, 2009. A total
of 280,902 new shares were subscribed for, providing SEK 28,090,200 million in
additional capital.
New employee option program. The new option program adopted by the annual
meeting of shareholders means that employees of the Diamyd Group were granted
new employee options as of April 1, 2009. A total of 158,400 options have been
granted to the management team and other employees of Diamyd Medical AB. The
program is running until 2011.
Diamyd Medical is discussing the possibility of combining its Phase III trials.
Diamyd Medical is conducting two clinical Phase III trials of the Diamyd®
diabetes vaccine in children and adolescents with recent-onset type 1 diabetes:
one in the US and one in nine European countries. At the same time, the company
is currently holding discussions with the regulatory agencies about combining
the two trials into one global trial. In addition to reducing costs,
consolidating the trials would
mean that countries with the fastest rate of patient recruitment could be
utilized to the greatest extent.
-- To read the complete report, please see attached pdf, or vist www.diamyd.com
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