Earnings release
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Arctic Bioscience Q3 2021 Operational Update • • • Psoriasis phase llb study for HRO350 on track : site feasibility process ongoing in Europe as planned with positive response from sites with access to patients for H1 2022 . New GMP manufacturing facility in Ørsta : Building process commenced , with planned finalization H2 2023. In - house manufacturing of our nutraceutical and investigational pharmaceutical products is expected to significantly improve company - wide gross margins . Full year adjusted EBITDA forecast in expected range of NOK -25 to -30 million Year - end cash position remains very solid , forecast in the range of NOK 200 to 220 million . Arctic Bioscience is a biotech company founded on the unique benefits of herring roe - with a pre - commercial pharmaceutical business and a commercial nutraceutical business . Pharma and Nutra share a proprietary technology and IP platform , including in - house R & D and value chain integration through a state - of - the - art GMP manufacturing facility . " The third quarter saw many positive developments for Arctic Bioscience , particularly in pharma and technology . During the period , site feasibility has been ongoing , with interest from a large number of sites in Europe for participation in the phase llb study for our drug candidate for treatment for mild - to - moderate psoriasis . We expect to initiate the study during the first half of 2022 according to plan . We are also happy to announce the building process has commenced for our new manufacturing facility in Ørsta , which will support both the pharmaceutical and nutraceutical businesses when finalized . While nutraceutical sales have been slower than expected in this unusual year , we remain in an excellent position to develop the company further on all fronts " , says CEO Ole Arne Eiksund in Arctic Bioscience . Pharmaceutical Arctic Bioscience is developing a novel , oral drug candidate ( HRO350 ) for the treatment of mild - to - moderate psoriasis . With approximately 90 % psoriasis patients suffering from mild - to - moderate disease , the addressable market is more than 20 million patients in the USA and the EU - 5 alone , corresponding to an annual revenue opportunity of more than USD 1 billion for the company . A large , randomized phase llb study scheduled to start in 2022. During the third quarter , site feasibility has been ongoing and a large number of sites in Europe have been identified for the phase llb study . First patient is planned to be enrolled in the study during H1 2022 . In addition to HRO350 , Arctic Bioscience has entered a collaboration with Smerud Medical Research for the development of a novel drug candidate for brain development in extremely premature infants , utilizing Arctic Bioscience's R & D capabilities and patented technology . SkatteFUNN has been granted and the project is developing according to plan . A market analysis report has been commissioned to provide financial projections for the potential use of such a drug . Technology and R & D As part of the company's strategy to retain proprietary know - how and IP and secure control of the value chain , Arctic Bioscience is building a state - of - the - art processing facility in Ørsta , Norway . The facility will significantly improve gross margins and increase long - term company profitability . The project is developing according to plan , with building work begun in August 2021 and planned finalization in the second half of 2023 . Nutraceutical