Bionor Pharma Positioned for Execution of the Kick, the Kill and the Boost Strategy, Aiming Towards a Functional Cure for HIV
(Oslo, Norway, 8 November 2013) Bionor Pharma ASA (OSE: BIONOR) announced today results from the third quarter and first nine months of 2013.
Webcast The Q3 report will be presented by webcast 8 November at 8.30 am CET. Link for registration and access to the webcast: http://www.media-server.com/m/p/zovaz8yn
See further information about the webcast and call numbers below.
During the quarter, the Company has secured financing for its new strategy to combine its therapeutic HIV vaccine candidate Vacc-4x with an HDAC inhibitor (HDACi) in the pursuit of a Functional Cure for HIV. The Company raised NOK 54.5 million in a private placement in September. Additional equity of NOK 20.6 million was raised in a subsequent offering after period end.
A Functional HIV Cure will enable people to live long-term with no disease progression or HIV transmission in the absence of conventional HIV medication. The new combination strategy which was launched earlier this year is called "Kick" (HDACi reactivation of virus), "Kill" (Vacc-4x's training of the cellular immune system leading to killing of virus infected cells) and "Boost" (stimulation of the immune system by lenalidomide to enhance the effect of Vacc-4x).
Romidepsin was selected as the preferred HDACi for the planned Vacc-4x/HDACi Phase I/II study (Kick and Kill trial). Romidepsin is so far the most potent HDACi for reactivation of HIV in cell systems. The Company made significant progress in planning the Kick & Kill study with the clinical research team from University Hospital of Aarhus led by Professor Lars Østergaard, Head of Infectious Diseases. Bionor Pharma and the Aarhus team are currently detailing the protocol for the study and are on track for filing the study application with the Danish Regulators & Ethical Committee by Q4 2013. Subject to study approval by the regulators and ethical committee, it is expected that enrollment of patients will be initiated in H1 2014.
The Vacc-4x Reboost Phase II and Vacc C5 Phase I/II trials are progressing according to plan and the Company is able to reconfirm its outlook that results are expected to be available in Q1 2014. Part B of the Vacc-4x and lenalidomide enrollment into the Phase II trial has slowed down in last part of October and is longer than anticipated due to screening failures (patients who did not meet inclusion criteria). Results from trial will be available eight months after last patient in (LPI) which is expected in December or January at the latest. Data from the part B is then expected in Q3 2014.
Bionor Pharma’s Chief Executive Office Anker Lundemose commented: “It has been an exciting quarter for Bionor Pharma and I am grateful for the confidence investors have shown the Company with the successful equity issue for the execution of the “Kick & Kill” strategy. We have selected the best HDACi for the study and we have raised the necessary capital – following an anticipated approval by the regulators, we are now positioned for execution”.
The Group reported a net loss of NOK 20.5 million in the third quarter (NOK 14.5 million) and a net loss of NOK 60.1 million (NOK 45.1 million) for the first nine months of 2013. The cash flow from operations in the third quarter was positive NOK 31 million (positive NOK 30.3 million) and the net cash position at period end was NOK 105.8 million (NOK 120.3 million).
A live audio webcast of the call will be available together with the slide presentation at http://www.media-server.com/m/p/zovaz8yn
For those without a computer available, and for ability to ask questions at the end of the presentation, use the following number: +44(0)20 3427 1910 (UK), +1212 444 0412 (US), +47 2316 2729 (Norway), +45 32 71 16 58 (Denmark) or +46(0)8 5033 6538 (Sweden), and request to be connected to the Bionor Pharma’s teleconference (confirmation code 1621620). Please use a quiet room.
Schedule for the webcast /teleconference 8 November (CET time)
08.25 -Log in to the webcast-link, and/or call the above number
08.30 -Review of results by Bionor Pharma’s senior management
-Questions and answers
Bionor Pharma ASA
Synne H Røine
Tel + 47 99 22 98 92
About Bionor Pharma ASA
Bionor Pharma is a leading biotechnology company, searching for breakthrough products for the treatment and prevention of life-threatening viral diseases. The Company is listed on the Oslo Stock Exchange, and is developing vaccines for viral infections. The vaccines are based on a proprietary technology platform developed following more than two decades of research into peptides, and they are designed to safely stimulate the immune system to combat viral diseases.
Global leader in the development of HIV vaccines
The Company has a leading position in the global research field for therapeutic HIV vaccines, and has two vaccine candidates in the clinical stage of development: Vacc-4x aims to induce long lasting virus control by training immune cells to seek out and kill virus-producing cells, and Vacc-C5 is designed to induce antibodies to HIV that can reduce the harmful hyperactivation of the immune system which can lead to AIDS. The foremost candidate, Vacc-4x, has shown a statistically significant reduction in viral load in a phase II randomized, multinational, double-blind, placebo-controlled study. The Company’s innovative technology platform is also well positioned to develop vaccines for other viral diseases, such as Influenza, HCV (Hepatitis C), HPV (Human papillomavirus) and CMV (Cytomegalovirus).
Four vaccine candidates in development
HIV vaccine, Vacc-4x: 1. Clinical Phase II study, combining Vacc-4x with Celgene’s immune modulator lenalidomide (Revlimid), to investigate whether lenalidomide enhances the effect of Vacc-4x in this placebo-controlled study in HIV patients with an impaired immune system.
2. Clinical Phase II study, with Reboost in patients from the previous phase II study, aimed at reducing viral load even further.
3. Planned clinical Phase I/II study, combining Vacc-4x with Celgene’s HDAC inhibitor (HDACi) Romidepsin, to reactivate and remove latent HIV infected cells from the reservoirs.
HIV vaccine, Vacc-C5: Clinical Phase I/II study, to investigate safety and whether the vaccine induces antibodies against HIV in humans.
HIV vaccine, Vacc-HIV (combination of Vacc-4x and Vacc-C5): A preclinical study is in preparation. The rationale behind Vacc-HIV is that this combination should prove more efficacious than each vaccine individually.
Universal influenza vaccine, Vacc-Flu: This vaccine is in the preclinical phase of development. Vacc-Flu is designed to produce long lasting immunity, and to be effective against all seasonal variations of influenza A.
More information about Bionor Pharma is available at www.bionorpharma.com.
This information is subject to the disclosure requirements of §5-12 vphl (Norwegian Securities Trading Act). Vacc-4x, Vacc-C5, Vacc-HIV, Vacc-Flu, Vacc-HCV, Vacc-CMV and Vacc-HPV are currently investigational treatments that have not been approved for marketing by any regulatory authority.