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2016-02-19

Saniona: Year End Report January - December 2015

SANIONA IS MAKING TWO PROJECTS READY FOR PHASE 2 AND CONTINUES TO
DEVELOP ITS BROAD PORTFOLIO

Financial highlights

Jan-Dec 2015 (Jan-Dec 2014)

· Net revenues were KSEK 13,630 (21,718)
· EBIT was KSEK -28,075 (-8,258)
· Earnings per share were SEK -1.10 (-0.43)
· Diluted earnings per share were SEK -1.10 (-0.43)

Q4 2015 (Q4 2014)

· Net revenues were KSEK 1,827 (3,720)
· EBIT was KSEK -5,327 (-6,243)
· Earnings per share were SEK -0.23 (-0.32)
· Diluted earnings per share were SEK -0.23 (-0.32)

Business highlights in Q4 2015

· Saniona and Ataxion extend their on-going drug discovery and
development collaboration with the aim of identifying a development
candidate.

· Rights issue is subscribed to 80.4% and the company raises about
SEK 48.8 Million before issue expenses, amounting to around SEK 5.3
million.

· New pre-clinical efficacy data for AN363 published at the Society
for Neurosciences 2015 Conference in Chicago along with new
scientific data in relation to the AN346 program.

· Saniona increased the shareholder base with more than 50% during
the 4thquarter 2015 primarily due to a significant interest from
Danish investors with a more than tenfold increase in number.

· Saniona initiated manufacturing of tablets for the Phase 2a
clinical study in type 2 diabetes with Tesomet after having completed
the validation and release of drug substance for clinical studies in
humans.

Significant events after the reporting period

· Saniona and Upsher-Smith Laboratories, Inc., through its
wholly-owned UK subsidiary Proximagen Ltd., sign collaboration
agreement for the research and development of therapeutics for
neurological disorders. Proximagen is granted exclusive worldwide
rights to develop, manufacture and commercialize medicines identified
through the collaboration. Saniona is entitled to pre-commercial
milestone payments of up to US$30 million (about SEK 250 million) and
tiered royalties on product sales.

· Saniona and Productos Medix, S.A de S.V sign a drug development
and commercialization collaboration. Medix is granted exclusive
rights to develop and commercialize tesofensine and Tesomet in Mexico
and Argentina. Medix will finance the clinical development in the two
countries. Medix intends to initiate Phase 3 clinical studies for
tesofensine for obesity later this year. Saniona retains all rights
to tesofensine and Tesomet in the rest of the world including
clinical data developed by Medix. Medix will pay Saniona an upfront
payment of US$ 1.25 million (about SEK 10.5 million), regulatory
milestone payments, and double-digit royalties on product sales.

Comments from the CEO

"Saniona took a significant leap forward during Q4 by announcing that
we now are planning for two Phase 2 studies during the first half of
2016. One for NS2359 and the other for Tesomet. We have made a flying
start during the first two months of 2016 by signing two new
partnership contracts with great financial potential. The new
contracts clearly show that we are committed to our objective of
financing most of our internal costs through partnerships," says
Jørgen Drejer, CEO of Saniona.

For more information, please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail:
tf@saniona.com

Letter from the CEO

"Saniona finished 2015 strongly. We closed our finance round in
November. We took a clear step forward towards initiating Phase 2
studies for Tesomet for type 2 diabetes in December. And a few days
later we could report that the Phase 2 study for NS2359 for cocaine
addiction will be initiated in 2016 together with our partner, TRC.

We also made a flying start in 2016 by signing a new Pharma
collaboration agreement with Upsher-Smith's subsidiary Proximagen,
where the pre-commercial milestone payments can reach around a
quarter billion Swedish kronor (US $30 million). This new agreement
relates to a project, which we have not communicated about
previously. It clearly demonstrates the value and strength of our
platform and broad portfolio of projects.

Yesterday, the flying start got even more momentum with the
announcement of the Medix collaboration for development of
tesofensine and Tesomet in Mexico and Argentina. This collaboration
is completely in line with our strategy of combining high ambitions
with a low burn rate. It brings us closer to the market and
represents a significant leap for Saniona. Medix intends to initiate
Phase 3 clinical trials for tesofensine and Phase 2 and Phase 3
clinical trials for Tesomet in obesity. Therefore, Medix may
potentially be the first company to introduce one of Saniona's
product candidates to the market, which may lead to a stable income
stream to Saniona through royalties on product sales in Mexico and
Argentina in the medium term. Moreover, Saniona will have the
exclusive rights to use the clinical data developed by Medix in the
rest of world. Our objective is to finance a significant part of the
internal costs through partnerships, which has been achieved with the
two new collaboration.

We are confident that we will be able to deliver on the
commercialization of our research efforts through all of our three
business models in 2016.

· New early stage partnerships - we are continuously in discussion
with a variety of pharmaceutical companies about potential
collaboration on our platform and research programs. The recent
agreement with Proximagen is the outcome of such discussions. We see
good opportunities to enter into additional agreements on our
platform and early stage programs.

· Own internal development - we expect to initiate two Phase 2
programs in 2016. Together with our partner TRC we plan to initiate
Phase 2 studies for the potentially first effective treatment for
cocaine addiction. Saniona has all the commercial rights to NS2359.
It is our intentions to apply for additional public funding together
with TRC for the continued development of NS2359, if the Phase 2
trial proves to be successful. In addition to the NS2359 program, we
expect to initiate Phase 2 studies for Tesomet. Tesomet represents an
innovative treatment approach for type 2 diabetes. Finally, we are
still investigating whether our preclinical candidate, AN363, can be
cleared for Phase 1 clinical studies for neuropathic pain. It is our
intention to build further value into these programs through early
clinical development before out licensing to 3rdparties.

· Joint ventures or spin-outs - our successful spin-out company
Ataxion continues to develop well in collaboration with Biogen and
Atlas Ventures who are the other shareholders. We retain an ownership
interest of 14 per cent of Ataxion after Biogen and Atlas Ventures
have committed to invest up to USD 17 million in the program. This
should enable Ataxion to take the lead program through Phase 1
clinical trials at which point Biogen has an option to acquire the
company. During 2016, we will look on additional opportunities for
establishing spin-outs and joint ventures which may be financed
through venture capital or through independent listings.

In summary, Saniona is in an increasingly strong position for the
future. Our achievements in 2015 show that our strategy of combining
low cost with high ambitions has delivered. At the turn of the year,
we have a strong balance sheet with SEK 47 million in cash. The
NS2359 Phase 2 program will be financed through public grants and we
expect to have enough capital to finalize the Phase 2 study for
Tesomet. We have partnering opportunities which may provide
additional financing and support the internal developed programs.

I want to take this opportunity to thank all our dedicated employees
at Saniona for their substantial achievements during the year. This
proves that hard work pays off. Also, I want to thank our
longstanding loyal shareholders for their support and welcome the
many new shareholders who decided to invest in Saniona during the 4th
quarter of 2015. The number of shareholders increased during the last
quarter of 2015 by 50%, a sign of trust, which we will do everything
we can to live up to."

Jørgen Drejer

CEO, Saniona AB

About Saniona

Saniona is a research and development company focused on drugs for
diseases of the central nervous system, autoimmune diseases,
metabolic diseases and treatment of pain. The company has a
significant portfolio of drug candidates at pre-clinical and clinical
stage. The research is focused on ion channels. Saniona has ongoing
collaboration agreements with Upsher-Smith Laboratories, Inc.,
Productos Medix, S.A de S.V and Saniona's Boston based spinout
Ataxion Inc., which is financed by Atlas Venture Inc. and Biogen Idec
Inc. Saniona is based in Copenhagen, Denmark, where it has a research
center of high international standard and 19 employees.

Vision and objective

Saniona will be a leading biotech company within the field of ion
channel-dependent diseases.

Saniona will discover and develop better medical treatments in areas
with significant unmet medical needs through modulation of ion
channels.

Business model

The company commercializes its research efforts through the following
3 business models:

· By internal development of selected programs through the early
phases of drug development before out-licensing to pharmaceutical
companies who will take over the further development of Saniona's
programs and typical pay upfront, milestone and royalty payments on
product sales to Saniona;

· Through early stage research and development collaboration with
pharmaceutical companies who will fund the research and development
activities and pay upfront, milestones and royalty payments on
product sales to Saniona; and

· Through joint ventures or spin-outs, where Saniona's financial
partner will obtain a share of the upside by financing the
development of one of Saniona's programs.

Project portfolio

Saniona has a significant portfolio of potential drug candidates at
pre-clinical and clinical stage. The clinical stage programs include
tesofensine and Tesomet, where the active ingredient tesofensine has
demonstrated strong weight reducing effects in Phase 2 clinical
studies in obese patients, and NS2359, which is a promising drug
candidate for the treatment of cocaine dependence. The company is
currently preparing a Phase 2a trial for Tesomet in type 2 diabetes
and a Phase 2a trial for NS2359 in cocaine addiction in collaboration
with the University of Pennsylvania's Treatment Research Center
(TRC). In addition, the company is collaborating with Productos
Medix, S.A de S.V, which is planning t...

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