Bionor Pharma - First Quarter 2015 results
(Oslo, 13.05.2015) Bionor Pharma ASA (OSE: BIONOR) announced today its financial results for the first quarter 2015 and update on its clinical development program.
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HIGHLIGHTS Q1 2015 AND BEYOND
New Management Team Appointed
REDUC trial (Vacc-4x + romidepsin) on track
Enrollment of patients in Part B of REDUC study completed
Results from effects on the HIV reservoir as expected in Q2 2015 disclosed 4 May 2015
The results of the interim analysis are promising and are detailed in this Report
Results from the effect of Vacc-4x and romidepsin on viral load are expected in H2 2015
New Board Appointments to be presented for election at the AGM 13 May 2015
The first quarter of 2015 was characterized by hiring a new CEO, Dr. David Solomon, and preparation of principal activities in order to establish a new Bionor. A large part of these activities, although initiated in first quarter of 2015, has effect beyond the first quarter giving this Q1 report, in part, a forward looking perspective.
Bionor Pharma’s principal strategy is to advance Vacc-4x in combination with other medicines in order to advance a functional cure for HIV patients and their caregivers.
As earlier reported, Part A of the REDUC trial demonstrated that the cancer drug, the HDAC inhibitor romidepsin (Istodax®), 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 decrease 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 announced, on 4 May 2015, after the Q1 reporting period, promising interim results from Part B. These are further described in this report, specifically the effect of the treatment on components of the viral reservoir. The company will report the results on viral load results in H2 2015.
Following the appointment of CEO Dr. David Horn Solomon in January 2015, Dr. Solomon has appointed a skilled and experienced team to join him as the Management Group at Bionor. The new members are: Jens Krøis, Chief Financial Officer, Barbara Ruskin, General Counsel and Chief Intellectual Property Officer, Kamilla Rolsted, Chief Strategy and Business Development Officer and Søren Keller, Chief Operating Officer. Detailed biographies of the Management Team can be found at www.bionorpharma.com.
CEO Dr David Horn Solomon commented, “Bionor as a therapeutic vaccine company represents leading efforts to establish an approach to a functional cure of HIV infection. I look forward to adding significant value to the Company together with the new Bionor team through advancing our therapeutic vaccine assets and by addressing the needs of patients and their caregivers.”
The Group reported a net loss of NOK 20.2 million in the first quarter (NOK 21.6 million). The cash flow from operations in the first quarter was negative NOK 17.8 million (negative NOK 18.4 million) and the net cash at period end was NOK 75.3 million (NOK 89.1 million).
Guidance 2015: Bionor Pharma ASA expects the core cost base to be in the range of NOK 55-63 million.
The company's core costs base refers to all costs that are required to run the business, excluding costs for clinical studies that can vary over time.
Notes for Editors
Bionor Pharma is a leading biotechnology company advancing the first therapeutic vaccine towards a functional cure for HIV. The company's focus is the research and development of peptide-based vaccines against viral diseases, primarily HIV.
Bionor Pharma's current clinical development pipeline comprises two vaccinecandidates for the treatment of HIV, Vacc-4x and Vacc-C5. Vacc-4x is the most advanced therapeutic vaccine in the HIV space and has demonstrated a reduction of viral load in a large, randomized, controlled Phase II trial, as well as safety and tolerability. Bionor Pharma's current clinical focus is to explore whether Vacc-4x, used with other medicines as a combination therapy, can reduce the viral load even further, and the company, through a collaboration with Celgene Corp, is investigating Vacc-4x and romidepsin in the REDUC study.
Bionor is listed on the Oslo stock exchange, under the ticker BIONOR.
More information about Bionor is available at www.bionorpharma.com.
This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
For more information please contact:
Bionor Pharma ASA
President and Chief Executive Officer David Solomon:
Tel +47 23 01 09 60
Consilium Strategic Communications
Mary-Jane Elliott / Ivar Milligan / Jessica Hodgson / Hendrik Thys
+44 (0)20 3709 5700