Amniotics AB (publ) Report for the First Quarter 2023
May 5, 2023
Clinical study completed
January – March in brief
- Total revenues: SEK 0 (0).
- Operating profit (EBITDA): SEK -10.8 (-10.6) million.
- Result for the period: SEK -11.8 (-11) million.
- Earnings per share: SEK -0.10 (-0.69).
- Cash flow for the quarter: SEK 31.2 (-11.2) million.
- Cash and cash equivalents at the end of the reporting period: SEK 40.3 (32.8) million.
- Equity/assets ratio as per the end of the reporting period: 17 (82) %.
- At the company's extraordinary general meeting on February 17, 2023, the meeting decided to approve the board's decision of January 17, 2023, on the rights issue of a maximum of 144,596,970 units.
- Amniotics carried out a preferential rights issue which brought the company SEK 25.3 million before issue costs and offsetting and repayment of outstanding bridging loans. Remaining loans after set-off and repayment amount to SEK 4.2m.
Events after the quarter
- Gerton Jönsson was appointed as the new CFO. Gerton Jönsson takes office on May 2, 2023.
Other events during the quarter
- The company received positive information about the safety data for PulmoStem™ in a clinical study. The company announced that safety has been established in the second cohort of the completed Phase Ib clinical trial investigating the lung-specific stem cell therapy PulmoStem™ in hospitalized patients with severe respiratory infections caused by COVID-19, RSV or other viral infections.
Clinical study completed
In the first quarter of 2023 Amniotics completed the first clinical phase I study of PulmoStem in
humans. The study included patients with severe lower respiratory tract infections caused by
viruses, including Covid-19. Positive data from the safety committee's evaluation could be reported.
That safety has been established at relevant dose levels is of great value for the company's
continued development program of PulmoStem.
The final report for the study is expected early in the third quarter of 2023. In parallel, the company
has already begun analysis of possible improvements to the practical aspects regarding
the preparation, handling and administration of PulmoStem. This type of product optimization is an
important part of product development, where we particularly focus on the usability of PulmoStem in
lung transplantation, which we see as a promising indication area. Discussions regarding a
continuation in the field of lung transplantation are ongoing with an interested research clinic.
The company carried out a rights issue during the first quarter, which was subscribed to 70 percent.
Of course, the company had hoped for a higher subscription rate, but considering the climate on
the capital market, we are still satisfied with the outcome. The strategic reorientation to actively
seek collaboration partners for our development projects instead of running the projects themselves
as before led to the company's carrying out a major reorganization of the company. It began in
the fourth quarter of 2022 and has continued according to plan. The company is now
significantly better equipped to meet the demanding market conditions. We have also been
able to strengthen the research and development organization with a specialist in the iPSC area
(general stem cells), which is connected to the Amniotics NK cell project. In this context,
it can be mentioned that the company worked on completing the necessary cooperation agreements
for the EU-supported consortium in the development of new NK cell-based therapies that
Amniotics leads. With agreements in place, the project has now officially started since the first of
April 2023. Total support that the consortium receives is EUR 3.8M and the project runs over
three years. In addition to Amniotics, the University of Copenhagen, Lund University and
Medizinische Hochschule Hannover are included.
In summary, the quarter has contained a number of strategic successes for the company, and we
are working further to refine these by focusing resources on research and development towards
our priority areas. The company has also increased efforts to seek strategic partners for
Lund, April 2023