Orphan Designation granted in EU

October - December in brief

• Total revenues: SEK 0 (0).
• Operating profit (EBITDA): SEK -5,0 (-9,8) million.
• Result for the period: SEK -5,8 (-10,9) million.
• Earnings per share: SEK –0,004 (-0,68).
• Cash flow for the quarter: SEK 4,6 (-14,5) million.
• Cash and cash equivalents at the end of the reporting period: SEK 8,2 (9,1) million.
• Equity/assets ratio as per the end of the reporting period: 60 (5) %.
• Amniotics carried out a rights issue that provided the company with SEK 25 million before issue costs as well as set-off and repayment of outstanding bridge loans.
• Amniotics has received renewed GMP certificate and authorization from the Swedish Medical Products Agency for the manufacture of clinical investigational drugs for advanced therapies based on mesenchymal stem cells isolated from amniotic fluid and for aseptic reconstitution of cell therapy products. The permit is valid until 2028-08-24.
• Amniotics has been granted Orphan Drug Designation for PulmoStem® for the treatment of Primary Graft Dysfunction in Lung Transplantation by the European Commission.

Other events after the end of the reporting period

• We have been undertaking additional work to strengthen the preclinical package PulmoStem-in-PGD and are currently aiming to treat the first patient in the second half of 2024.
• The management and the board work actively to identify and evaluate various possible solutions to secure the Company's financing needs.

January - December in brief

• Total revenues: SEK 0 (0).
• Operating profit (EBITDA): SEK -27,1 (-46,7) million.
• Result for the period: SEK -30,9 (-48) million.
• Earnings per share: SEK -0,06 (-2,99).
• Cash flow for the period: SEK -0,9 (-34,9) million.

CEO statement

Orphan Designation granted in EU

A major milestone was reached for the company when the European Commission granted Orphan Designation status for PulmoStem in preventing Primary Graft Dysfunction (PGD) in lung transplantation. This gives the company several benefits during the PulmoStem product development, and a ten-year market exclusivity once the medicine is on the market. We have been working with our academic partner to plan the PulmoStem-in-PGD study in the most efficient and cost-effective way we can. We have been undertaking additional work to strengthen the preclinical package and are currently aiming to treat the first patient in the second half of 2024.

Leveraging Amniotics’ manufacturing assets to provide contract services (CDMO) has remained in focus. We believe there is a poorly served niche to support academic developers and academic spin-out companies who need flexible low cost CDMO services. We have continued to promote our services at relevant congresses and via direct approach to companies and academia.

The optimization of the production of our lead candidate, PulmoStem, has continued with a strong focus on the cost of goods. The knowledge gained from this work will also feed into our CDMO offering.

Our CNS project, CogniStem has been progressing and we are currently investigating the CNS homing mechanisms and related biochemical effects in the brain together with an academic research group at Lund University.

The NK-consortium project is on track with each consortium partner attending their separate work packages and a yearly project assembly will be held in the second quarter of 2024.

Last autumn, we carried out a rights issue. Since the net cash supplied to Amniotics did not secure the Company's working capital for the next twelve months, the plan was that the deficit would be financed by the cash that Amniotics could be supplied upon redemption of the warrants series TO3 that were issued in the rights issue where the redemption period runs during the period 26 February – 8 March 2024. In light of the fact that the Company's share is today traded below the redemption price for TO3 of 1 öre per share, it is currently uncertain to what extent Amniotics will receive the capital injection that the TO3 warrants were planned to provide. Management and the board are now working intensively on various possible solutions to the Company's capital needs. So far we do not have a ready solution to present, but the work continues with high intensity.

Lund, February 2024
Marcus Larsson

https://www.amniotics.com/investors/financial-reports/