Q1 2016 Interim Financial Report
Bionor Pharma ASA
Interim Financial Report
1 January – 31 March 2016
11 May 2016
HIGHLIGHTS Q1 2016
In the first quarter of 2016, Bionor continued its preparation of the BIOSKILL trial and other clinical activities. Additional clinical trial applications for BIOSKILL were forwarded to competent authorities, and the company also reported further data from the REDUC Part B trial. The company’s working capital was strengthened with the support from existing and new shareholders in a NOK 45 million private placement and a subsequent NOK 16 million repair offering.
- REDUC Part B results, primarily related to latent reservoir size, were given as an oral presentation at the prestigious Conference on Retroviruses and Opportunistic Infections (CROI), in Boston, MA (USA)
- Bionor announced that the third and final assay for measuring latent HIV reservoir size, the primary endpoint in the REDUC Part B trial, supports that the combination of Vacc-4x and the latency reversing agent romidepsin (Istodax®, Celgene) leads to a reduction in latent viral reservoir
- Clinical trial applications for the BIOSKILL clinical trial were submitted to authorities in France and Australia, and approval was obtained in Denmark and the United Kingdom. In addition, a request for a pre-IND meeting with the U.S. Food and Drug Administration (FDA) was submitted
- Bionor was granted up to NOK 9.2 million from Research Council of Norway to further advance Vacc-4x in a combination treatment regimen
- The company’s shareholders approved the completion of a private placement raising NOK 45 million in gross proceeds, which is expected to fund the company through the first half of 2016, and a subsequent repair offering for existing shareholders raising gross proceeds of NOK 16 million
- A new Chairman and two new board members were elected at an extraordinary general meeting on 11 March 2016
- Net cash flow in Q1 2016 was NOK -31.2 million (Q1 2015: NOK -17.8 million)
- Cash and cash equivalents at 31 March 2016 was NOK 41.8 million (31 March 2015: NOK 75.3 million).
Events after the balance sheet date
- At the company’s annual general meeting on 22 April 2016, a number of resolutions were rejected by the shareholders. Mr. Steen Krøyer was elected as new board member, replacing Thomas Hofstaetter. An extraordinary general meeting will be convened shortly to handle the rejected proposals
- On 26 April 2016, the company announced that Dr. David Horn Solomon and Bionor’s Board of Directors had agreed that Dr. David Horn Solomon on the same day would leave his position as Chief Executive Officer of Bionor Pharma ASA, owing to a shareholder led change in company strategy. The Board of Directors will initiate a search process for a new CEO. Until such search is concluded, the Board has appointed MSc Pharm Unni Hjelmaas as acting CEO
- Three board members, Benedicte Fossum, Kirsten Drejer and Jerome B. Zeldis resigned from the Board on 28 April 2016.
Financial guidance for 2016
For the full year 2016, Bionor maintains its financial guidance of a Core cost base in the range of NOK 58-66 million. The Core cost base is defined as Employee Benefit Expenses plus Other operating expenses.
Per S. Thoresen, Chairman of the Board of Directors, commented:
“The new Board maintains its focus on HIV immunotherapy and the overall strategy to advance Vacc-4x in combination with other medicines in order to contribute to a possible functional HIV cure. With 36 million people world-wide living with HIV, it is of paramount importance that treatment options for HIV-positive individuals are improved. We have a strong asset in Vacc-4x, and as Board and company, we look forward to advancing our functional HIV cure strategy to the future benefit of HIV-positive individuals and their caregivers as well as to our shareholders. The timing and details in the clinical development program as well as the core cost base are under consideration in light of the company’s cash position and market capitalization. Any possible changes will be disclosed in due course in a stock exchange announcement.”
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
Per S. Thoresen, Chairman of the Board of Directors, +47 906 14 620
Jens Krøis, CFO, +45 2080 1668, email@example.com
Jørgen Fischer Ravn, VP Investor Relations & Communications, +45 2030 3903, firstname.lastname@example.org
Bionor Pharma is a Norwegian biopharmaceutical company focused on advancing its proprietary therapeutic vaccine Vacc-4x in combination with other medicines toward a functional HIV cure. The company believes it has first mover potential based on clinical results to date and early adoption of now recognized clinical strategy. In December 2015, Bionor announced that the HIV ’Shock & Kill’ trial REDUC with Vacc-4x and romidepsin successfully met its primary endpoint by reducing latent HIV reservoir and further demonstrated control of viral load. Bionor currently retains full ownership rights to Vacc-4x, i.e., the upside potential from partnering or licensing remains with the company. Bionor is based in Oslo, Norway, and also has offices in Copenhagen, Denmark and New York, USA. Bionor is listed on Oslo Børs (OSE:BIONOR). More information about Bionor is available at www.bionorpharma.com.
A PDF of the full Interim Financial Report for Q1 2016 is available here.