Media

Amniotics AB (publ) Report for the third Quarter 2023

Regulatory

November 27, 2023

100 % guaranteed rights issue

July – September in brief

  • Total revenues: SEK 0 (0).
  • Operating profit (EBITDA): SEK -5.6 (-15.3) million.
  • Result for the period: SEK -6.7 (-16.4) million.
  • Earnings per share: SEK -0.03 (-1.02).
  • Cash flow for the quarter: SEK -2.2 (-5.5) million.
  • Cash and cash equivalents at the end of the reporting period: SEK 3.6 (23.6) million.
  • Equity/assets ratio as per the end of the reporting period: -115 (31) %.
  • In addition to existing cash, the company has a new loan commitment of SEK 5 million to finance continued development of the existing business in accordance with the business plan.
  • The company has prolonged the loan to Buntel AB(former Modelio Equity AB(publ)) 4,2 MSEK plus interest.
  • On 31 August 2023, the Board of Directors of Amniotics resolved, subject to subsequent approval at the Extraordinary General Meeting on 3 October 2023, to carry out an issue of a maximum of 2,502,044,100 units, consisting of shares and warrants, with preferential rights for the company's existing shareholders. The Company can receive a maximum of approximately SEK 25 million before issue costs in the rights issue. The Rights Issue is 100% secured and is covered by subscription commitments, bottom, and top guarantee commitments.
  • During the period the company has received the finalized clinical study report for the Phase Ib clinical trial of the cell therapy product candidate PulmoStem which was evaluated in patients with severe lower airway infections caused by Covid-19, Influenza A, and RS-virus. The report confirms the previously announced positive topline results for safety and tolerability.
  • The Singapore Patents Registry has approved a patent application for the company’s amniotic fluid collection technology. This patent, no. 10201609919W, “Cells, methods and apparatuses for amniotic fluid collection and isolation of cells”, provides Amniotics with protection for this technology in Singapore at least until 2034.

January – September in brief

  • Total revenues: SEK 0 (0).
  • Operating profit (EBITDA): SEK -22.1 (-36) million.
  • Result for the period: SEK -25 (-38.1) million.
  • Earnings per share: SEK -0.12 (-2.37).
  • Cash flow for the period: SEK -5.5 (-20.4) million.
  • Amniotics carried out a rights issue that provided the company with SEK 25.3 million before issue costs and set-off and repayment of outstanding bridge loans. Outstanding loans after set-off and repayment amount to SEK 4.2 million.
  • Gerton Jönsson was appointed new CFO. Gerton Jönsson took office on May 2, 2023.
  • Been able to present the primary endpoint for the PulmoStem Phase I study was achieved.
  • In June, the outcome of the warrant program TO2 was announced, where it was gratifying that the coverage ratio was over 90%.
  • The company was also granted a key patent in the EU for the company's technology platform, including PulmoStem, which is valid until at least 2040.
  • Promising data on our product candidate CogniStem was presented in June at an international stem cell symposium.

Other events after the end of the reporting period

• The Extraordinary General Meeting on 3 October resolved on two reductions of the share capital; one for loss coverage and one for allocation to non-restricted equity, as well as related amendments to the limits for the number of shares and share capital in the Articles of Association. As a result of the two reductions, the share's quota value decreased from approximately SEK 0.054089 to SEK 0.0024. The AGM also resolved to approve the Board of Directors' resolution of 31 August 2023 on a rights issue of a maximum of 2,502,044,100 units consisting of shares and warrants series TO3.

  • On October 27, the Board of Directors announced the outcome of the rights issue of units consisting of shares and warrants series TO3, which was announced on August 31. In total, 54.3% of the rights issue was subscribed for with unit rights. In addition, approximately 1.7 percent of the rights issue, without the support of unit rights, was subscribed for and approximately 44.0 percent of the rights issue was subscribed for by guarantors. The Rights Issue was thus subscribed to 100 percent and through the rights Issue, Amniotics initially received approximately SEK 25 million before issue costs. Through the rights issue, the number of shares in Amniotics increased by 2,502,044,100, and the share capital increased by SEK 6,004,905.84.
  • The company have received a positive statement from the Committee for Orphan Drug Status (COMP) at the European Medicines Agency (EMA) for PulmoStem (AmnioPul-02) designation as orphan medicinal product for the treatment of Primary Graft Dysfunction (PGD) following lung transplantation.

CEO Statement
100% guaranteed rights issue

During the third quarter, the company was able to present a 100% guaranteed rights issue of SEK 25M and when this CEO's speech is written, the transaction is complete. I take the fact that Amniotics was able to make this transaction in the currently harsh investment climate as a sign of strength.

The company has received the final study report for the PulmoStem Phase Ib study in severe lower respiratory tract infection, which confirmed the previously communicated positive topline data for safety and tolerability in both evaluated dose levels. Our main clinical program is aimed at the treatment of severe complications in lung transplants, so-called Primary Graft Dysfunction (PGD) with our lung-specific cell therapy candidate PulmoStem.

Happily, we have received a positive statement from the Committee for Orphan Drug Status (COMP) at the European Medicines Agency (EMA) for this treatment indication, which I see as a validation of both the PulmoStem project and the company's technology platform. We have continued the planning work for a Phase I study in PGD starting in the first half of 2024.

Our GMP production facility (where we develop and manufacture our cell therapy

candidates) has been inspected by the Swedish Medical Products Agency during the quarter and our manufacturing license has been extended until 2028. Within our NK- cell project, the work has progressed, both within continued basic research and through collaborations within the EU-supported NK consortium we lead. The company's patent portfolio has been further strengthened during Q3 by a granted patent in Singapore for Amniotic's amniotic fluid collection technology.

Finally, I would like to extend a big thank you to the previous and new owners who made our rights issue a success.

Lund, November 2023
Marcus Larsson

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

Upcoming events

Read more

Subscribe