Report for the Second Quarter 2022


August 16, 2022

PulmoStem™ entering clinical phase

April – June in brief

  • Total revenues: SEK 0 (0).
  • Operating profit (EBITDA): SEK -10.2 (-17.2) million.
  • Result for the period: SEK -10.7 (-17.7) million.
  • Earnings per share: SEK -0.66 (-1.11).
  • Cash flow for the quarter: SEK -3.6 (13.6) million.
  • Cash and cash equivalents at the end of the reporting period: SEK 29.1 (8.9) million.
  • Equity/assets ratio as per the end of the reporting period: 65 (88) %.
  • The company received approval by regulatory authorities in UK and Sweden for its first clinical trial with PulmoStem™. The study is a first-in-human Phase I/II study in hospitalized COVID-19 patients aiming to investigate the safety and tolerability of different doses of PulmoStem™.
  • Amniotics AB has taken out a short-term loan of SEK 15 million. The proceeds from the loan will be used to continue the development, and the existing operations in accordance with existing business plan until the end of 2022.
  • The Annual General Meeting held on 15 April 2022, re-elected Anders Månsson, Marcus Larsson, Christopher Bravery, Fredrik Tiberg, Ingrid Atteryd Heiman and Peter Buhl Jensen as board members. Peter Buhl Jensen was re-elected to serve as chairman of the board.
  • Amniotics presented positive preclinical data on stem cell treatment for chemotherapy-induced peripheral neuropathy at ICRBE 2022. The results show that treatment with MSC selected for neural specificity (CogniStem™) have significant positive efficacy on chemotherapy-induced hearing loss and chemotherapy-induced neuropathic pain.

January – June in brief

  • Total revenues: SEK 0 (0).
  • Operating profit (EBITDA): SEK -21.6 (-30.2) million.
  • Result for the period: SEK -21.7 (-30.2) million.
  • Earnings per share: SEK -1.35 (-1.90).
  • Cash flow for the quarter: SEK -14.8 (8.4) million.
  • Amniotics received a grant of SEK 4,8 million from Sweden’s Innovation Agency, Vinnova, together with Skåne University Hospital to demonstrate proof of concept of using Amniotics stem cell therapy to repair damaged discarded donor lungs for transplantation and for reducing the incidence of unwanted side-effects after lung transplantations.

Other events after the end of the reporting period

  • US Patent and Trademark Office (USPTO) has approved a patent application for the company’s stem cell product PulmoStem™.

CEO Statement
It is with great satisfaction that I can state that during second quarter we delivered real breakthroughs for Amniotics. During the quarter, we received approval for our first clinical study. Our business within contract manufacturing has been strengthened through new hires in the production team during the quarter. We have also done changes in our product portfolio for the coming year where we intend to prioritize the company's resources on PulmoStem™ within the indications Covid-19/ARDS (Acute Respiratory Distress Syndrome) and lung transplantation as well as NK cells in oncology. This aims to optimize the company's capacity and financial resources in the areas where we see the greatest potential in the near term.

Our focus during the quarter has been the upcoming phase I/II study with PulmoStem – Amniotics lung-specific stem cell therapy developed for the treatment of lung diseases where inflammation and fibrosis are key factors, for example ARDS, covid-19 with or without ARDS and acute rejection of graft in case of lung transplantation. Covid-19-related ARDS is the first indication in our clinical development program for PulmoStem.

Patients with Covid-19 who become seriously ill may develop ARDS requiring intensive care. Unfortunately, there is a great deal of chronic morbidity in the aftermath of those affected by ARDS, even after moderate illness. Up to 10 percent have permanent problems. Today there is a lack of drugs with a satisfactory effect against ARDS triggered by Covid-19 and the treatment consists of a combination of symptom relief and preventive therapies. Due to the pandemic, ARDS has increased sharply. In Sweden and globally, Covid-19 is still a health problem with the development of new variants, increasing spread of infection and hospitalization. The burden on healthcare has affected our preparations for the planned phase I/II study on hospitalized Covid-19 patients at risk of developing severe ARDS. The study is our first clinical study in humans with the aim of investigating the safety and tolerability of intravenous dosing at different doses of PulmoStem.

During the quarter, we received approval from regulatory authorities in Sweden and United Kingdom to start the study, and during the summer we worked on completing the trial centres and producing product for the study. We expect to recruit the first patients in the near future and the results from the study are expected, as previously announced, in the second half of 2023.

The results from the study on Covid-19 patients will be important for further studies with PulmoStem in other lung and respiratory diseases, for example lung damage in connection with lung transplantation. The prognosis for lung transplant patients is poor and an estimated 30 percent develop the serious complication primary graft dysfunction (PGD). During the quarter, results from a preclinical lung transplantation study carried out by Professor Sandra Lundstedt’s group at Lund
University and Skåne University Hospital were presented. It showed a statistically significant and medically relevant reduction in the number of PGD cases when treated with PulmoStem. We are now planning for a phase I/II study in 2023, in lung transplantation with the support of the planned clinical study in Covid-19 patients.

NK cell therapies (Natural Killer cells) have been shown in several clinical studies to be effective against hematological and solid tumours. We see great potential in the field, which is also the reason why NK cell therapies in oncology now are a part of our prioritized product portfolio. Amniotics have previously described a new method for generating hematopoietic stem cells (HSCs) and NK cells that may lead to new treatment approaches for some of the most serious forms of cancers.

In the cancer field, we presented promising new preclinical data for the treatment of chemotherapy-induced peripheral neuropathy (CIPN), a very common side effect of chemotherapy treatment, with mesenchymal stem cells at the ICRBE conference in Zurich in July. The results show the potential breadth of the use of CogniStem™ as a treatment in conjunction with cancer therapy. The results are a clear validation of Amniotics platform and our therapeutic approach. And this will be further strengthened through development of our for-runner PulmoStem.

During the quarter, Amniotics has expanded with new employees, and strengthened our finances, to enable our intensive research work. We have an exciting autumn ahead of us and we feel well prepared for the challenges we face with the goal of being able to help seriously ill people to a better life.

Lund, August 2022 
Kåre Engkilde

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