Bionor Pharma - Fourth Quarter 2014 results

(Oslo, 25.02.2015) Bionor Pharma ASA (OSE: BIONOR) announced today its financial results for the fourth quarter and preliminary full year 2014 and update on its clinical development program.

Link to webcast starting at 08.30 http://edge.media-server.com/m/p/h9qzm5ds

Link to Q4 report and Q4 presentation

  • Dr David Horn Solomon appointed new CEO
  • REDUC trial (Vacc-4x + rompidepsin) on track
    • Enrollment of patients in part B of REDUC study completed
    • Results from effects on the HIV reservoir expected in Q2 2015 results from effect on viral load is expected in H2 2015
  • “Boost & Kill” trial  - Vacc-4x + lenalidomide Phase II study read out November 2014
    • Vacc-4x + lenalidomide increased CD4 counts
    • Treatment was well tolerated
  • World’s AIDS Day 2014 focuses on the possibility for finding a functional cure and puts focus on therapeutic vaccines

Bionor Pharma’s principal strategy is to take the best results from our ongoing clinical trials in order to advance a product for HIV patients and caregivers.

As earlier reported, Part A of the REDUC trial demonstrated that the cancer drug, the HDAC inhibitor romidepsin, was able to reactivate or “kick” the assumed 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 Company expects to be able to announce the effect of the treatment on components of the reservoir late in Q2 2015 and the results on viral load results in H2 2015. 

The phase II Vacc-4x + lenalidomide known as the “Boost & Kill” study trial read out in the fourth quarter. The study included HIV positive persons receiving cART, who had not regained a healthy CD4 level. Results showed that the combination of Vacc-4x and Celgene’s immunomodulator Revlimid® (lenalidomide) increased CD4 count (p=0.009). The treatment was well tolerated.  The results indicate that the effects of Vacc-4x can be boosted by lenalidomide. This gives the option to add the “Boost & Kill” to Bionor Pharma’s current “Kick & Kill” development strategy towards achieving a functional cure for HIV.

Bionor Pharma appointed Dr David Horn Solomon as new President and CEO after the reporting period ended. Dr Solomon has extensive experience as a CEO in listed biotech companies, healthcare investing and pharmacology research. Prior to joining Bionor Pharma Dr Solomon was CEO of Zealand Pharma A/S (Nasdaq CO: ZEAL) from 2008 until 2015. Dr Solomon studied medicine and immunology at Cornell Medical College and the Sloan Kettering Cancer Center in New York where he received his doctorate in 1991. Dr Solomon has served as a faculty member at Columbia University’s College of Physicians and Surgeons.

The World AIDS Day 1 December 2014 celebrated the progress made within HIV research and focused on the importance of finding a cure for a HIV. The focus was also put on vaccines as a possible mean to end HIV/AIDS (US NIH Statement World AIDS Day 2014).

Incoming CEO Dr David Horn Solomon commented, “Bionor represents leading efforts as a therapeutic vaccine company to establish an approach to a functional cure of HIV infection. I look forward to adding significant value to the Company together with the Bionor team by addressing the needs of patient and their caregivers.”

The Group reported a net loss of NOK 14.7 million in the fourth quarter (NOK 25.4 million). The cash flow from operations in the fourth quarter was negative NOK 10.6 million (negative NOK 17.2 million) and the net cash at period end was NOK 93.1 million (NOK 107.5 million).