Preparing for clinical phase

July - September in brief

  • Total revenues: SEK 0 (0) thousand.
  • Operating profit (EBITDA): SEK -9,778 (-5,437) thousand.
  • Result for the period: SEK -10,211 (-5,998) thousand.
  • Earnings per share: SEK -0.64 (-0.54).
  • Cash and cash equivalents at the end of the reporting period: SEK 54,158 (9,754) thousand.
  • As a consequence of the exercise warrants series 2017/2021 and series 2018/2021, the share capital increased by 204,500 shares and the proceeds to the company amounts to SEK 1,842 thousand.
  • Equity/assets ratio as per the end of the reporting period: 92 (88) %.
  • Nasdaq Stockholm approved trading of Amniotics shares and warrants on Nasdaq First North Growth

 
January - September in brief

  • Total revenues: SEK 0 (0) thousand.
  • Operating profit (EBITDA): SEK -39,088 (-15,782) thousand.
  • Result for the period: SEK -40,380 (-17,145) thousand.
  • Earnings per share: SEK -2.55 (-1.54).
  • Cash flow for the period: SEK 53,648 (3,727) thousand.
  • In the second quarter Amniotics raised SEK 60 million for the Company before issue expenses in a rights issue.


Events after the end of the reporting period

  • Lars Stigsson, a member of the Board of Directors of Amniotics AB (publ) resigned from the Board of Directors of the company on 12 October 2021.
  • The members of the Nomination Committee were appointed and consists of: Christer Fåhraeus, Marcus Larsson, Lars Stigsson represented by Fredrik Tiberg and Peter Buhl Jensen, Chairman of the Board of Amniotics AB.


CEO Statement
Activity level was high in the third quarter, and we saw a continued growth in Amniotics organization and capabilities. With new members onboard, including external consultants, within the clinical and production area we have a trajectory set for continued focus on development and increasing the value of our programs.

During the quarter we have continued working on our pipeline. For our most advanced development project targeting ARDS/COVID-19, the core documents for the planned clinical trial in 2022 will soon be completed. We have advanced as expected and a number of clinical sites will be participating in the upcoming trial. The trial is thoroughly planned and will be finalized in collaboration with our Clinical Research Organization (CRO). We work closely with our CRO, and we are setting up the trial with risk mitigation strategies to keep pace with the development of the disease and to avoid any disruptions.

In addition to the advances in the planning of the study, we are currently manufacturing stem cells that will be used in humans in the ARDS/COVID-19 study. We have successfully completed a number of batches during the quarter and I’m happy to see that the quality, yield and manufacturing processes are in line with what we predicted. During the last quarter of the year, we will continue to manufacture batches of stem cells that will be used in the planned study in 2022.

Some of our peers within in the field of stem cells have shown effect with their investigative stem cell products. This despite COVID-19 being a disease which has experienced a changing treatment regimen during time and across continents. This makes it harder to show efficacy. With our peers results at hand, we have a strengthened belief in Amniotics PulmoStem product for this indication.

The ongoing COVID-19 pandemic is far from over. With new outbreaks and a virus that is mutating, there is currently a great need for an effective treatment for lung diseases related to this and the need will remain for a long time to come. FDA has created a special emergency program for possible coronavirus therapies, the Coronavirus Treatment Acceleration Program (CTAP) to move new treatments to patients as quickly as possible. Currently there are 660 drug development projects in planning stage.

“Continued progress executing on our strategy.”
Along with the progress in trial planning for COVID19, Amniotics has also started to look into our two others respiratory indications and started to engage with clinical sites and clinicians.

Peers have shown potential effect in neurology indications. They produce MSCs with a different approach than the one Amniotics uses for CogniStem. We believe that CogniStem can deliver comparable or even stronger effects with its neonatal origin and neural specificity.

In Amniotics ongoing pre-clinical program in pediatric neurology indication, we expect data outcome in Q4 this year and we expect to present this in 2022. As mentioned in our Q2 report earlier this year, Amniotics has strong pre-clinical data in lung transplantation, and we expect this data will be presented in 2022.

I am proud to mention that Amniotics was selected as a one of the “Rising Stars” by the Swedish American Life Science Society (SALSS) in mid-October.

I look forward to a continued eventful last quarter of 2021 and the preparation of the planned phase I study in ARDS/COVID-19 as the next important milestone.

Lund, November 2021


Kåre Engkilde, CEO

For further information, please contact:


Kåre Engkilde
CEO, Amniotics AB
Phone: +46 (0) 723 27 85 20
Email: ke@amniotics.com
 
Johny Humaloja
CFO, Amniotics AB
Phone: +46 (0) 735 06 68 56
Email: jh@amniotics.com

The financial reports will be made available on the Amniotics website:
https://www.amniotics.com/investors/financial-reports/

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 HospitalUniversity 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 also has also an, by Läkemedelsverket (Swedish MPA in Sweden), approved GMP (Good Manufacturing Practice (GMP) manufacturing facility to produce Advanced therapy Therapy medicinal Medicinal products Products (ATMPs). With the GMP facilities operational since 2020, Amniotics is now moving into clinical trials with the leading drug candidate, PulmoStem™ and 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.

Amniotics Certified Adviser on First North is Redeye AB, certifiedadviser@redeye.se, telephone: +46 (0) 8 121 576 90.

The company is listed at Nasdaq First North Growth Market in Stockholm.

Learn more at www.amniotics.com. 

Attachments

Q3 Report EN Amniotics

© Modular Finance, source Nordic Press Releases