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Bionor Pharma - Third quarter results 2014

(Oslo, 04.11.2014) Bionor Pharma ASA (OSE: BIONOR) announced today its financial results for the third quarter 2014 and update on its clinical development program.

Download the Q3-report and Q3-presentation

  • Successful capital raise with gross proceeds of NOK 52.9 million to
    • Keep the scientific momentum created by the successful presentation at AIDS 2014 in Melbourne
    • Position company to the best possible options following data readout in 2015
  • Progress of ongoing clinical trials on track
    • Enrollment of patients in part B in REDUC study completed
    • Last patient out in August in the IMiD + Vacc-4x study, results expected in Q4
  • GLOBVAC confirms grant of NOK 16.8 million of REDUC study
  • Clinical Development team strengthened with the appointment of Dr. Shahin Gharakhanian as executive consultant 

During the third quarter of 2014, the results from Part A of the REDUC trial were presented at the 20th International AIDS conference in Melbourne, Australia. The results were well received by the HIV key opinion leaders and the scientific community. The Company was subsequently able to raise NOK 52.9 million in additional funding to keep the scientific momentum and initiate detailed planning and preparation of the next steps in the development strategy. The Company’s goal is to uphold and advance its first mover position in the search for a functional cure for HIV and thereby position the Company for the best possible options following data readout in 2015.

Part A of the REDUC trial demonstrated that the cancer drug, the HDAC inhibitor romidepsin, was able to reactivate or “kick” the so-called latent virus reservoirs in HIV patients while on conventional HIV medication, cART (combination antiretroviral therapy).

The objective of the ongoing part B of the REDUC trial is to investigate whether the effects of Vacc-4x vaccination followed by romidepsin treatment impacts the latent HIV reservoir and viral control. Romidepsin “kicks” the virus out of reservoirs making the HIV infected cells visible to the immune system. The immune response generated by Vacc-4x will then make it possible for the white blood cells to attack and “kill” the infected cells. This immune response will then lead to a potential reduction of the latent HIV virus reservoirs and viral load. The reduction of reservoirs and the reduction in viral load following a monitored cART treatment pause are the key outcomes of the REDUC part B study. The trial is on track and the enrollment of patients is completed. The results regarding the effect on the size of the HIV reservoir are expected H1 2015 and viral load results are expected in H2 2015.

The Company has received confirmation of the size of REDUC grant from GLOBVAC. GLOBVAC will support the REDUC study with NOK 16.8 million over three years. The grant was first announced in Bionor Pharma’s first quarter 2014 report. This is the third time Bionor Pharma receives a grant from GLOBVAC (The Research Council of Norway).

The IMiD + Vacc-4x (“Kill & Boost”) study is progressing according to plan and “last patient, last visit” was in August. The results from the study are expected in Q4 2014. The objective of the IMiD + Vacc-4x trial is to investigate the additive effects of Celgene’s IMiD (immune modulator) Revlimid® on Vacc-4x vaccination. Positive results open the possibility to “boost” the effect of Vacc-4x in a pursuit of a functional cure for HIV or to add IMiD + Vacc-4x to the treatment of HIV patients with a discordant immune system who have low CD4 immune cells.

Bionor Pharma has strengthened its clinical development team with the appointment of Dr. Gharakhanian as executive consultant. Dr. Gharakhanian MD, DPH is specialized in HIV and infectious diseases. He has over 20 years’ experience in clinical medicine and from the pharmaceutical industry. His last position was Vice-President Medicines Development Group/Medical Affairs, Global R&D of Vertex Pharmaceuticals.

“I am grateful for the confidence investors and GLOBVAC once again have shown Bionor Pharma.” says Bionor Pharma’s CEO Dr. Anker Lundemose. “With the newly raised funds we are now enabled to uphold and advance our first mover position in the execution of our Kick & Kill strategy. Detailed planning of the next clinical steps is initiated and we are eagerly awaiting the upcoming readout of the IMiD+Vacc-4x trial”

The Group reported a net loss of NOK 14.7 million in the third quarter (NOK 20.5 million). The cash flow from operations in the third quarter was negative NOK 14.5 million (negative NOK 20.3 million) and the net cash at period end was NOK 103.7 million (NOK 105.8 million).

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