April - June in brief
Events in the quarter
January - June in brief
Events after the end of the reporting period
The first half of 2021 has shown a tremendous advancement for Amniotics in many aspects. To accelerate value creation, we successfully completed a fully subscribed rights issue, raising SEK 60 million, prior to listing on Nasdaq First North Growth Market on July 6th. It is encouraging to see the considerable interest in Amniotics. I would like to take this opportunity to sincerely thank both the new and existing shareholders that have invested for their trust. The capital raised will be used to finance the upcoming clinical study of PulmoStem™ and to ramp up the development of our pipeline.
During the first six months, Amniotics has made additional progress with the pre-clinical development of our pipeline PulmoStem™ was investigated for lung transplantations to prevent PGD ‘Primary Graft Dysfunction’ and has shown promising data in a pre-clinical animal study. The study shows significant and medical relevant reduction of Primary Graft Dysfunction and there were no adverse events identified. Amniotics will seek scientific and regulatory advice to determine the development and regulatory path in lung transplantations. Our ongoing feasibility study of Cognistem™, to show the potential within neurological disorders, is following the plan and the first technical batches of Cognistem™ have been manufactured in our GMP facility in Lund. Amniotics received a license to manufacture advanced therapy investigational medicinal products in Q4 2020. During the period, a routine inspection of our manufacturing facilities by the Swedish Medical Products Agency was successfully completed and we are now in the process of manufacturing PulmoStem™ for our upcoming clinical trials.
In order for Amniotics to accelerate the development of our product portfolio we have strengthened our organization with additional production, quality, and R&D scientists. In addition, Amniotics senior management team was strengthened with the recruitment of Jonny Humaloja as CFO with responsible for financial management, reporting and Investor Relations. Humaloja comes to Amniotics with significant financial executive experience in the life science sector. Most recently he served as a CFO for the biotech company Genovis.
“We are focused on advancing our broader purpose as an organization, as we aim to pioneer stem cell science for the betterment of humanity.”
Looking ahead - our focus is on the preparing and initiating the PulmoStem™ clinical trial scheduled to recruit the first patient in 2022. In addition, our aim is to advance additional product candidates and pursuing discussions with potential partners with interest in our technology platform and pipeline of innovative regenerative medicines.
We are working diligently to create stakeholder value, and the development in the first six months give us confidence that 2021 will be a busy and interesting year for Amniotics.
Again, thank you for your continued support,
Lund, August 2021
Kåre Engkilde, CEO