LARGE-SCALE PRODUCTION AND TOXICITY STUDIES
Production of the company’s silica for preparative chromatography in large scale proceeds according to plan. Commercial material is expected to be delivered at the end of the year, after which the company can start delivering on customer agreements. At the same time, we continue to strengthen our platform in inhalation and respiratory diseases with a comprehensive tox program and increased resources for development and commercialization.
Net sales for the second quarter amounted to TSEK 4,497, most of which comes from the partner project with Vicore Pharma AB. Our assessment of continued growth remains, subject to the fact that individual quarters may vary.
Within preparative chromatography, which is now our main focus within the Chromatography business area, the production of commercial product at ton scale is proceeding according to plan. Larger volumes of material are expected at the end of the year, after which delivery of product against the six-year agreement worth approximately MSEK 120 we signed in China in 2019 can begin. Deliveries are expected to start at the end of this year or early next year.
It is delightful that we have received an initial order in the US market for the evaluation of our silica for preparative chromatography. This confirms that we are starting to reach customers in the US as well. In Asia, we have now delivered larger volumes of material samples from early production batches to the potential customers with whom we are in dialogue. These samples are part of their evaluation process, and this brings us one step closer to selling larger volumes. Our products are an integral part of complex industrial processes. Several dialogues are making good progress, but it is difficult to say when in time additional supply agreements can be concluded. As society opens up, we plan to attend conferences to launch our products in preparative chromatography. The first conference we will participate in is the Beijing Conference and Exhibition on Instrumental Analysis (BCEIA) in September.
In Drug Development, toxicity studies with our inhalation platform NLAB Spiro® are currently being performed. Results from the first study are expected during the third quarter, after which further planned studies will be carried out. In parallel, intensive development work on the platform is ongoing, where we for example are working with release profiles and loading mechanisms for various substances, including biological drugs. We also intend to generate preclinical data for some model molecules after which we will be able to set up a clear plan for future programs.
To lead the development and commercialization of the NLAB Spiro® platform, Ulf Ericsson has been recruited as VP Drug Development. Ulf Ericsson most recently comes from AstraZeneca where he was Global Sr Director Respiratory Inhalation and was responsible for the commercial development of inhalers and inhaled formulations. With Ulf’s vast experience, we are taking a major step in strengthening our competence in the field.
During the third quarter, material from the first batch of GMP-manufactured NLAB Spiro® silica particles will be delivered to Vicore Pharma for their VP02 program. VP02 is based on Nanologica’s technology platform and is an inhalable formulation of thalidomide for the treatment of IPF (idiopathic pulmonary fibrosis) and the severe cough that the disease brings. According to Vicore Pharma, the project is planned to move into clinical studies next year, which will be an important milestone for our inhalation platform.
In summary, we can put another quarter of growth behind us and are in the near time confidently looking forward to large-scale production, exciting customer meetings and great opportunities for our inhalation platform NLAB Spiro®.
July 9, 2021
/Andreas Bhagwani, CEO
CEO Comment Second Quarter 2021
LARGE-SCALE PRODUCTION AND TOXICITY STUDIES
Production of the company’s silica for preparative chromatography in large scale proceeds according to plan. Commercial material is expected to be delivered at the end of the year, after which the company can start delivering on customer agreements. At the same time, we continue to strengthen our platform in inhalation and respiratory diseases with a comprehensive tox program and increased resources for development and commercialization.
Net sales for the second quarter amounted to TSEK 4,497, most of which comes from the partner project with Vicore Pharma AB. Our assessment of continued growth remains, subject to the fact that individual quarters may vary.
Within preparative chromatography, which is now our main focus within the Chromatography business area, the production of commercial product at ton scale is proceeding according to plan. Larger volumes of material are expected at the end of the year, after which delivery of product against the six-year agreement worth approximately MSEK 120 we signed in China in 2019 can begin. Deliveries are expected to start at the end of this year or early next year.
It is delightful that we have received an initial order in the US market for the evaluation of our silica for preparative chromatography. This confirms that we are starting to reach customers in the US as well. In Asia, we have now delivered larger volumes of material samples from early production batches to the potential customers with whom we are in dialogue. These samples are part of their evaluation process, and this brings us one step closer to selling larger volumes. Our products are an integral part of complex industrial processes. Several dialogues are making good progress, but it is difficult to say when in time additional supply agreements can be concluded. As society opens up, we plan to attend conferences to launch our products in preparative chromatography. The first conference we will participate in is the Beijing Conference and Exhibition on Instrumental Analysis (BCEIA) in September.
In Drug Development, toxicity studies with our inhalation platform NLAB Spiro® are currently being performed. Results from the first study are expected during the third quarter, after which further planned studies will be carried out. In parallel, intensive development work on the platform is ongoing, where we for example are working with release profiles and loading mechanisms for various substances, including biological drugs. We also intend to generate preclinical data for some model molecules after which we will be able to set up a clear plan for future programs.
To lead the development and commercialization of the NLAB Spiro® platform, Ulf Ericsson has been recruited as VP Drug Development. Ulf Ericsson most recently comes from AstraZeneca where he was Global Sr Director Respiratory Inhalation and was responsible for the commercial development of inhalers and inhaled formulations. With Ulf’s vast experience, we are taking a major step in strengthening our competence in the field.
During the third quarter, material from the first batch of GMP-manufactured NLAB Spiro® silica particles will be delivered to Vicore Pharma for their VP02 program. VP02 is based on Nanologica’s technology platform and is an inhalable formulation of thalidomide for the treatment of IPF (idiopathic pulmonary fibrosis) and the severe cough that the disease brings. According to Vicore Pharma, the project is planned to move into clinical studies next year, which will be an important milestone for our inhalation platform.
In summary, we can put another quarter of growth behind us and are in the near time confidently looking forward to large-scale production, exciting customer meetings and great opportunities for our inhalation platform NLAB Spiro®.
July 9, 2021
/Andreas Bhagwani, CEO
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