Date: 2016-05-31
Type of information: Restructuring
Compound:
Company: Bionor Pharma (Norway)
Therapeutic area: Infectious diseases
Type agreement: restructuring
Action mechanism:
Disease:
Details: * On May 31, 2016, Bionor Pharma announced that the Board of Directors has completed its review of the company’s strategy and financing plans in accordance with the considerations presented in stock exchange announcement of 28 April 2016. The company maintains its focus on HIV immunotherapy and overall strategy to further advance Vacc-4x in clinical development in combination with other medicines to develop a functional cure for HIV. The timing and details in the clinical development program have been revised in light of the company’s cash position and market capitalization, and a two-step funding plan is outlined below. Clinical strategy: Bionor deploys a “Shock and Kill” approach for achieving a functional cure for HIV infection. This reflects a prevailing view in the HIV scientific community that a combination of different compound classes is likely required to achieve long-lasting viral control in the absence of ART. As part of this approach, Bionor will continue investigating the combination of Vacc-4x with a latency reversing agent (romidepsin) to first educate the immune system to recognize and kill infected cells, followed by an activation of the latent HIV in infected cells to make them visible to the immune system. It is expected that a third agent will be needed for the purpose of further improving the immune response. Bionor believes that a crucial step in validating this approach was taken with the REDUC clinical trial, which demonstrated that Vacc-4x led to improved control of HIV in the blood after the virus had been “shocked” out of its latent reservoir by romidepsin, and met its primary end point by leading to a reduction of the latent HIV reservoir. Based on the REDUC data, Bionor is currently planning BIOSKILL, a multicenter placebo-controlled proof of concept Phase II clinical trial, as well as an exploratory Phase I/II trial to evaluate an immune regulating agent administered in a triple agent regimen with Vacc-4x and romidepsin (BIONAB). Finally, a trial is planned to document the effect of the adjuvant GM-CSF on Vacc-4x immunogenicity. This is a clinical trial planned to provide data requested by the FDA. Bionor has been granted approximately NOK 20 million from Skattefunn for the BIOSKILL clinical trial, and the Research Council of Norway has granted the company up to NOK 9.2 million to partially fund the BIONAB trial. The company will continue to pursue non-dilutive funding. Bionor Pharma also announced that Benedicte Fossum, Kirsten Drejer and Jerome B. Zeldis collectively resign with immediate effect as board members in Bionor Pharma ASA owing to a shareholder led change in company strategy. * On April 26, 2016, Bionor Pharma announced that Dr. David Horn Solomon and Bionor’s Board of Directors have agreed that Dr. David Horn Solomon will 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 immediately initiate a search process for a new CEO. Until such search is concluded, the Board has appointed MSc Pharmacist Unni Hjelmaas as acting CEO. The Board thanks Dr. Solomon for all his service for Bionor Pharma ASA during his tenure for the company.
Based on the clinical strategy outlined above, Bionor’s capital need is now estimated by the Board to approximately NOK 230-270 million, which covers the period from the third quarter of 2016 to the fourth quarter of 2019 (14 calendar quarters); approximately nine months after the expected announcement of BIOSKILL topline results in the first quarter of 2019. Previously, Bionor estimated the capital need until the first quarter of 2019 to NOK 375-425 million (11 calendar quarters). The significantly reduced, estimated capital need is based on a planned, major reduction of the core cost base for the period, a slightly narrowed clinical development plan, and less focus on further expanding the company’s asset pipeline. Bionor will seek to reduce the costs for running the company by relocating to other facilities in Norway, Denmark, and the U.S. In addition, an organizational review is currently ongoing. As part of this review, it has been decided not to replace Søren Keller, SVP and Chief Operating Officer, who will leave the company by 1 June 2016. The Board has considered various transaction structures to fund the continued development of the company’s assets. Taking into account the need for funding, execution risk, transaction costs and cash position of the company as well as the clinical status of Vacc-4x, the Board has decided that the company’s long-term funding initially will be covered by an equity offering to fund the company through the following 6-12 months. Further details on the timing, size, and structure of this transaction will be disclosed in due course. Concurrently, the Board will investigate the possibilities of securing the remainder of the long-term capital need through equity, non-dilutive means, or a combination thereof. Enrollment in each of the clinical trials will only be initiated when funding has been secured to complete the trial. Based on this new funding strategy, enrollment of first patient in BIOSKILL is planned for the first quarter of 2017.
* On April 28, 2016, Bionor Pharma announced that the Board of Directors is currently reviewing the company’s strategy and financing plans and will announce any possible changes in due course in a stock exchange announcement. The company maintains its focus on HIV immunotherapy and overall strategy to advance Vacc-4x in combination with other medicines in order to contribute to a possible functional HIV cure. The timing and details in the clinical development program is under consideration in light of the company’s cash position and market capitalization.
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