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Bionor Pharma ASA: Bionor Pharma - First quarter results 2014

(Oslo, 14.05.2014) Bionor Pharma ASA (OSE: BIONOR) announced today its first
quarter 2014 results. The results from the clinical trials and the
identification of a potential biomarker in the first quarter 2014 have shaped
the way forward for the development of Vacc-4x and Vacc-C5.

Results from part A of the REDUC trial was announced earlier this week. Part A
demonstrated that the dose of 5 mg/m2 of the HDAC inhibitor (HDACi)
romidepsin was able to reactivate or "kick" the so-called latent virus
reservoirs in HIV patients while still on conventional HIV medication, cART.
Only minor adverse events were observed. Part B of the REDUC study will
investigate the ability of Vacc-4x to eliminate or "kill" infected HIV cells
following romidepsin reactivation of the latent HIV reservoir and reducing
the reservoir. Agreement for free supply of romidepsin was entered into with
Celgene in the quarter. Enrollment of patients for part B is expected to
start in Q2 2014. Results regarding the effect on the size of the HIV
reservoir may be available in H1 2015 whereas results from the overall study
are expected in H2 2015.

Bionor Pharma has been granted GLOBVAC funding for the REDUC study and it is
the third time the Company is granted funding from GLOBVAC. The grant is for
up to NOK 16.8 mill over a three year period, exact size of grant is subject
to final discussions with GLOBVAC.

The results from the Vacc-4x Reboost Phase II study were announced in the
quarter. The results confirmed Vacc-4x' ability to reduce viral load, but the
effects of reboosting was not statistically significant. Several patients did
however experience a further reduction in viral load.

The retrospective, exploratory subset analysis of the large Vacc-4x Phase II
2010 study identified elevated C5 antibodies as possible biomarker to
identify patients that are more likely to have an improved response to
Vacc-4x ("responders"). Patients with elevated antibodies experienced a
reduction in viral load after Vacc-4x vaccination of 88 % or log 0.94
compared to viral load before commencing cART whereas reduction in viral load
for all patients was log 0.4 or 60% (p=0.0001). It is estimated that
approximately 20-30 % of HIV patients have elevated C5 antibodies.

In February the Phase I/II Vacc-C5 results were announced. The results showed
that the vaccine was well tolerated and was able to increase C5 antibodies
levels in HIV patients with low pre-existing C5 antibodies. Bionor Pharma
plans to develop Vacc-C5 in combination with Vacc-4x, Vacc-HIV, to enhance
the effects of Vacc-4x vaccination.

The results from the Vacc-4x 2010 trial have been published in The Lancet
Infectious Diseases (2014; 14: 291-300). The journal also published an
editorial of the role of therapeutic vaccines in the treatment on HIV.

This quarter's data analyses and results reconfirm Bionor Pharma's overall
development strategy for its HIV vaccines. The development strategy for
Vacc-4x is centered on the exploration of monotherapy in a subset of HIV
patients characterized by elevated C5 antibodies (biomarker), as well as the
"Kick, Kill and Boost" strategy exploring Vacc-4x in combination with other
medications in the search for a Functional Cure for HIV. The "Kick" refers to
HDACi reactivation of virus. The "Kill" is Vacc-4x' training of the cellular
immune system leading to killing of virus infected cells. The "Boost" is the
stimulation of the immune system by IMiD (lenalidomide).

"It has been one of the most eventful quarters in Bionor Pharma's history. The
results from the trials and analysis have brought the development of Vacc-4x
forward." says CEO Dr. Anker Lundemose "The identification of a potential
biomarker for Vacc-4x and the promising results from part A of the REDUC
trial reconfirms our development strategy to enhance the effects of Vacc-4x
and are key in our pursuit to find a functional cure for HIV patients."

The Group reported a net loss of NOK 21.6 million in the first quarter (NOK
18.3 million). The cash flow from operations in the first quarter was
negative NOK 18.4 million (negative NOK 16.8 million) and the net cash at
period end was NOK 89.1 million (NOK 89.2 million).

Bionor Pharma ASA
CFO Synne H. Røine +47 99 22 98 92

This information is subject of the disclosure requirements pursuant to section
5-12 of the Norwegian Securities Trading Act.

Q1 2014 Presentation
Q1 2014 Report


This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Bionor Pharma ASA via Globenewswire


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