Report for the Fourth Quarter 2021
February 17, 2022
Vinnova grants to develop stem cell therapies
October – December in brief
· Total revenues: SEK 0 (0).
· Operating profit (EBITDA): SEK -12.4 (-13.9) million.
· Result for the period: SEK -13.2 (-13.9) million.
· Earnings per share: SEK -0.82 (-1.24).
· Cash and cash equivalents at the end of the reporting period: SEK 44 (0.5) million.
· Equity/assets ratio as per the end of the reporting period: 85 (79) %.
· Amniotics filed a Clinical Trial Application (CTA) for its planned Phase I/II study with its lead candidate drug in lung specific mesenchymal stem cells PulmoStem™.
· Amniotics joined the research project Centre for Advanced Medical Products (CAMP), a consortium funded by a SEK 48 million grant with the aim of improving the outcome of lung transplantations using PulmoStem™.
January – December in brief
· Total revenues: SEK 0 (0).
· Operating profit (EBITDA): SEK -51.6 (-29.4) million.
· Result for the period: SEK -53.6 (-31) million.
· Earnings per share: SEK -3.34 (-2,78).
· Cash flow for the period: SEK 43.5 (-5.5) million.
· In the second quarter Amniotics raised SEK 60 million in a rights issue and SEK1.2 million through exercise of warrants.
· In the second quarter Nasdaq Stockholm approved trading of Amniotics shares and warrants on Nasdaq First North Growth Market.
Events after the end of the reporting period
· In January 2022 Amniotics, together with Professor Sandra Lindstedt at Skåne University Hospital, received a Vinnova grant of SEK 4,8 million. The funds will be used to demonstrate proof of concept of using Amniotics stem cell therapy to repair damaged discarded donor lungs for transplantation.
· Amniotics hired Matilda Hugerth to serve as Head of Clinical Development. Hugerth assumed the position in January and is responsible for clinical development and regulatory affairs.
2021 has been an incredibly exciting year for Amniotics on several levels. We have made significant progress that enables the phase I / II study on the healing of degenerative lung injuries with our unique drug candidate PulmoStem™ can be started soon. We have also taken our other projects closer to the clinic and we have strengthened our clinical and regulatory capacity. In addition, PulmoStem is central in future trial-led studies that have received significant amounts of grants from the Vinnova foundation. One of the main achievements during the year was the listing of the company on the First North Growth Market and the associated new share issue, which provided the company with both new shareholders and capital. The listing is a significant milestone in Amniotics history and is a natural next step on the growth journey.
One of our main tasks during the year, on which we have invested a lot of resources and time, has been the thorough preparations for Amniotics first clinical study in humans. A phase I / II clinical study with one of our unique drug candidates, PulmoStem, which is being developed for treatment of degenerative lung injuries. In the fourth quarter, we reached an important milestone when we submitted the application to start the clinical study, a so-called Clinical Trial Application (CTA), to the relevant authorities in Europe. The planned phase I / II study will be conducted on hospitalized patients with SARS-CoV-2 coronavirus. The primary goal of the study is to evaluate safety and tolerability, in combination with potential early efficacy readouts on inflammation, fibrosis and fatigue. We expect to include the first patient in the study during the first half of 2022.
Due to the development of the pandemic, with new variants and peaking infection numbers, we find it important to consider alternative treatments, such as stem cell therapies, that are not focused on antiviral drugs. Amniotics’ stem cell therapy product PulmoStem is agnostic to the corona variants and in general to the inflammatory lung insults but is instead expected to halt the inflammatory process and potentially start to regenerate damaged lung tissue. Thus, it has the potential to be useful in a large number of different respiratory indications.
During the year, we saw great interest in our research from the academia, which has resulted in two exciting projects with Professor Sandra Lindstedt at Skåne University Hospital in Lund. With a grant of close to SEK 5 million from the Vinnova Foundation, she is now starting up a clinical study together with Amniotics. The purpose is
is to study whether Amniotics cell therapy can make more donated lungs suitable for transplantation. In addition, Amniotics has also joined the research project Center for Advanced Medical Products (CAMP), a consortium funded by a grant of SEK 48 million with the aim of improving the outcome of lung transplants using PulmoStem. Furthermore, we have seen an interest both from smaller biotech companies and from larger pharmaceutical companies regarding the possibility for Amniotics to work as a contract manufacturer for others.
"Increased interest in Amniotics research work globally, both in academia and industry"
To continue on our growth journey, we strengthened and built our capacity in several areas during the year. In order to strengthen the clinical and regulatory capacity, and to ensure that our clinical trial progresses, Mathilda Hugerth has been hired as head of clinical development.
To summarize, I’m very pleased to see that Amniotics over all is delivering on its strategy. Amniotics vision is to develop life changing treatments and we believe that our unique drug candidate PulmoStem has that potential. I am exceedingly honored to lead this innovative team and, together with colleagues, board members and partners, to develop stem cells that can potentially improve the lives of people suffering from severe lung diseases. We are now looking forward to the next important milestone for Amniotics – to start our first clinical study with patients in COVID-19 / ARDS.
Lund, February 2022
Kåre Engkilde, CEO
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