Diamyd Medical is engaged in discussions regarding an extension of GABA/Diamyd® trial in Birmingham, Alabama

Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced in
its second quarterly report for the fiscal year 2015/2016 that the Company is
engaged in discussions regarding an extension of the ongoing GABA/Diamyd®-trial
in Birmingham, Alabama. The Company also announced that the associated company
Companion Medical, Inc. has submitted a 510(k) Premarket Notification in the US
as well as a CE-mark application in Europe.
Moreover, the CEO’s comments in today’s quarterly report reads as follows.

The second quarter of this fiscal year and the period thereafter have been
exciting and eventful. We presented preliminary reports from three different
ongoing combination studies with the diabetes vaccine Diamyd®: 1) DIABGAD
(Diamyd®/ibuprofen/vitamin D); 2) DIAGNODE (intralymphatic injection of
Diamyd®/vitamin D); 3) EDCR (Diamyd®/etanercept/vitamin D), and all have shown a
good safety profile thus far. We applied for and, after the end of the period,
received approval from both the Swedish Medical Products Agency and the Ethics
Review Board for a certain extension of the DIAGNODE trial, and we are engaged
in discussions regarding an extension of the GABA/Diamyd® trial in
Birmingham/Alabama. An agreement was signed with Uppsala University Hospital to
conduct a new investigator-initiated trial with the combination of GABA/Diamyd®,
however, the trial startup is pending discussions with the Medical Products
Agency and necessary subsequent approvals.

Cellaviva AB, which is now in business saving stem cells from umbilical cords,
and in which we have a shareholding of about 45%, is currently conducting a
bridge financing and has appointed the undersigned as Chairman. According to
many experts, stem cells may revolutionize regenerative and immunomodulatory
therapies for autoimmune, neurological, metabolic, and cardiovascular diseases,
as well as cumulative trauma disorders. Pending evidence for this, so that
public funds possibly may be earmarked for family saving of umbilical cord stem
cells, perhaps primarily for children in risk groups – such as the children of
parents with diabetes or other autoimmune or genetic risk predispositions – it
may be important for Sweden’s future position within the pharmaceutical
industry, that such industry closely cooperates with pharmaceutical research in
joint development efforts. Cellaviva’s early adopters – i.e. its customers – can
therefore be described as breaking new ground for future, not-yet fully
identified, medical applications for own (autologous) stem cells. Diamyd
Medical’s prime interest is to find ways to differentiate umbilical cord stem
cells into insulin-producing beta cells, and we have now initiated an
international application for funding of such research. We have also conducted a
field trip to one of the world’s leading umbilical cord blood banks in Los
Angeles.

Together with a representative from Eli Lilly, we also visited our “8%
shareholding” in San Diego, Companion Medical Inc., which is developing a smart
pen for insulin administration, and we are pleased to report that a 510(k)
Premarket Notification as well as a CE-mark application for clearance to sell
smart insulin pens in Europe have been submitted. However, no forecast or
timeframe for these applications are given.

Finally, a rights issue was implemented, which was over-subscribed to 207
percent and generated MSEK 22 to Diamyd Medical. At today’s date, our cash funds
therefore amount to approximately MSEK 40.

As previously reported, the plan for our world-leading Antigen Based Therapy for
type 1 diabetes, is to evaluate the diabetes vaccine Diamyd® – which has shown a
good safety profile in trials with more than 1,000 patients – together with
various other compounds to receive guidance on which treatment regimen that is
best able to enhance the effect (16%, p=0.1) that was achieved in a previous
European Phase III trial. We aim to cure type 1 diabetes by first inducing
immunological tolerance to the insulin-producing beta cells and then restore the
functional beta cell mass by stem cell therapy.

We are moving forward according to plan. To create value for you, our
shareholders, and for you, with type 1 diabetes.

About Diamyd Medical
Diamyd Medical is dedicated to finding a cure for autoimmune diabetes through
pharmaceutical development and investments in stem cell and medical technology.

Diamyd Medical develops the diabetes vaccine Diamyd®, an Antigen Based Therapy
(ABT) based on the exclusively licensed GAD-molecule. The Company’s licensed
technologies for GABA and Gliadin have also potential to become key pieces of
the puzzle of a future solution to prevent, treat or cure autoimmune diabetes,
and also certain inflammatory diseases. At this time six clinical studies are
ongoing with Diamyd®. Diamyd Medical is with its holdings of 45% one of the
major shareholders in the stem cell company Cellaviva AB. Stem cells can be
expected to be used in Personalized Regenerative Medicine (PRM), for example for
restoration of beta cell mass in diabetes patients where the autoimmune
component of the disease has been arrested. Diamyd Medical also has holdings in
the medtech company Companion Medical, Inc., San Diego, USA and in the gene
therapy company Periphagen, Inc., Pittsburgh, USA.

Diamyd Medical’s B-share is traded on Nasdaq Stockholm First North under the
ticker DMYD B. Remium Nordic AB is the Company’s Certified Adviser.
For further information, please contact:
Anders Essen-Möller, President and CEO
Phone: +46 70 55 10 679. E-mail: anders.essen-moller@diamyd.com
Diamyd Medical AB (publ)
Kungsgatan 29, SE-111 56 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8
661 63 68
E-mail: info@diamyd.com. Reg. no.: 556242-3797. Website: www.diamyd.com.