First patient cohort treated with PulmoStem™

October - December in brief

  • Total revenues: SEK 0 (0).
  • Operating profit (EBITDA): SEK -9.8 (-13.2) million.
  • Result for the period: SEK -10.9 (-13.2) million.
  • Earnings per share: SEK -0.68 (-0.82).
  • Cash flow for the quarter: SEK -14.5 (-10.2) million.
  • Cash and cash equivalents at the end of the reporting period: SEK 9.1 (44) million.
  • Equity/assets ratio as per the end of the reporting period: 5 (85) %.
  • The company announced that it will change the strategic direction and scope of operations to reduce costs in both the short and long term.
  • The company has terminated the liquidity providing agreement with Lago Kapital regarding liquidity providing for the company's shares.
  • Amniotics was invited to sign a 3.8 MEUR grant agreement with the European Innovation Council (EIC) from the Pathfinder program, as part of a consortium. The project aims to develop and improve Natural Killer (NK) cells for cancer treatments.
  • The company decided to advance the publication of quarter 4 2022 report to January 19, 2023.


Other events during the quarter

  • Amniotics was granted US patent for its oncology program AMNI-NK003.
  • In October the first patient was dosed in the company's phase Ib study with PulmoStem™.


Significant events after the end of the quarter

  • The company called an extraordinary general meeting on Friday, February 17, 2023.
  • The board of Amniotics AB, subject to subsequent approval at an extraordinary general meeting on February 17, 2023, decided to carry out a rights issue of 144,596,970 units, consisting of shares and warrants, with preferential rights for the company's existing shareholders of a maximum of approximately SEK 36.1 million, corresponding to approximately SEK 31 million after customary issue costs. The right issue is guaranteed to 70 percent. In the event of full utilization of the warrants, at the maximum subscription price, Amniotics may receive a maximum of approximately SEK 70 million after transaction costs.
  • In connection with the rights issue, Amniotics has renegotiated the outstanding loans taken out from Modelio Equity AB and Fårö Capital AB in May 2022. After the rights issue, the remaining amount of loans will amount to a maximum of SEK 4.0 million from Modelio Equity AB, while Fårö Capital AB's loans will to be regulated in its entirety. The loan is extended until 30 September 2023 and continues to run with a monthly interest rate of 1.5 percent.


January - December in brief

  • Total revenues: SEK 0 (0).
  • Operating profit (EBITDA): SEK -46.7 (-51.5) million.
  • Result for the period: SEK -48 (-53.6) million.
  • Earnings per share: SEK -2.99 (-3.34).
  • Cash flow for the period: SEK -34.9 (43.5) million.


CEO Statement
Result from the first patient cohort supports safety

Amniotics began the fourth quarter of 2022 by achieving an important milestone by administering amniotic fluid-derived mesenchymal stem cells to humans for the first time. This phase Ib study evaluates the lung-specific cell product PulmoStem in hospitalized patients with Covid-19 and other severe respiratory viruses such as e.g., influenza. During the quarter the first patient cohort was completed. Positive initial safety data in these patients means we could proceed to the next dose level.

Through the work with PulmoStem, Amniotics has shown the ability to take a discovery from the laboratory through solid development work to trial in a clinical study.

Another pleasing development during the quarter was that Amniotics was invited to lead an EU consortium for the development of Natural Killer (NK) cells in cancer therapy. This EIC-Pathfinder grant runs over three years, and the total grant amount is 3.8 MEUR. The consortium includes the University of Copenhagen, Hannover Hochschule and Lund University. Designated NK003, the project will develop generic NK cells for large-volume production using Amniotic's cell culture technologies. In addition to their intrinsic effect against cancer cells, the cells are equipped with targeting surface receptors that enhance the anti-cancer effect. Cell therapies in cancer treatment are a very promising area with great growth in recent years. However, the treatments today are limited because they are completely individualized for each individual patient and thus very costly. The aim of NK003 is to be able to offer patients treatment with generally useful immunologically highly active cells in cancer treatment. We look forward with confidence to driving the NK-cell project further, internally and within the consortium. During the last quarter this year Amniotics has been granted an important patent in the USA for the oncology program AMNI-NK003.

A strategic review of the Company's operations has also been carried out during the quarter and led to a further focusing of Amniotic's operations on activities that are clearly creates value in the relatively near term. This means significant savings and unfortunately also staff reductions. The savings program is expected in the long term to lead to the Company's running costs being reduced by approx. 75%. The uncertain climate in the capital market for early-stage development companies in biotechnology is an important reason why we needed to adapt our operational activities. Furthermore, on January 17, the board decided on a rights issue which is guaranteed to 70%, and conditional on approval at an extraordinary general meeting on February 17, 2023. In connection with the rights issue being carried out, the debt burden for the company be significantly reduced.

In 2023, we will continue with the ongoing clinical study, which looks very promising, as well as an exciting NK-cell project that is funded by the EU, and a clearly focused strategy with a lower cost mass. I now, together with my team, look forward with confidence to an exciting 2023 when we will reach several milestones.

Lund, January 2023
Marcus Larsson

For more information please contact

Marcus Larsson
CEO, Amniotics AB
Phone: +46 (0) 763 0840 91
Email: ml@amniotics.com

or
Johny Humaloja
CFO, Amniotics AB
Phone: +46 (0) 735 0668 56
Email: jh@amniotics.com

About Amniotics

Amniotics is a biopharma company focusing on mesenchymal stem cells (MSC) from amniotic fluid. The company was born out of the discovery of a novel source of stem cells in full-term amniotic fluid. Based on a decade of research at the internationally recognized Lund University Stem Cell Centre and the Skåne University Hospital of Lund, the company is pioneering the harvesting and propagation of tissue specific neonatal quality mesenchymal stem cells (MSC). These stem cells have unique properties for applications in regenerative medicine. Amniotics has also an, by Läkemedelsverket (Swedish MPA), approved Good Manufacturing Practice (GMP) facility to produce Advanced Therapy Medicinal Products (ATMPs). With the GMP facilities operational since 2020, Amniotics is now in clinical phase with the leading drug candidate PulmoStem™. The company is looking to establish strategic partnerships with researchers and companies that are interested in developing stem-cell-based therapies targeting diseases with high unmet needs.

Amniotics (publ) has it´s headquarter in Lund, Sweden.

The company is listed at Nasdaq First North Growth Market in Stockholm.
Amniotics Certified Adviser at First North is Redeye AB, e-post: certifiedadviser@redeye.se.
Learn more at www.amniotics.com. 

Attachments

Q4 2022 EN Amniotics

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