Interim Report, 1st Quarter 2022


May 10, 2022

January – March in brief
· Total revenues: SEK 0 (0).
· Operating profit (EBITDA): SEK -10.6 (-12.1) million.
· Result for the period: SEK -11 (-12.5) million.
· Earnings per share: SEK -0.69 (-1.35).
· Cash flow for the quarter: SEK -11.2 (22) million.
· Cash and cash equivalents at the end of the reporting period: SEK 32.8 (22.5) million.
· Equity/assets ratio as per the end of the reporting period: 82 (71) %.
Amniotics received a grant of SEK 4,8 million from Sweden’s Innovation Agency, Vinnova, together with Professor Sandra Lindstedt at Skåne University Hospital. The grant will be used 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.

Significant events after the end of the reporting period
· In April, Amniotics raised short-term loan totaling SEK 15 million to finance the continued development and start of clinical studies and the existing operations in accordance with the existing business plan.

Other events after the end of the reporting period
· In April Amniotics 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™

CEO Statement
The COVID-19 pandemic has taken hold again, especially in Asia. Even in the Western world, we see that it is still reaping victims. Given the developments we are currently seeing, with new variants and high infection levels, it is important to consider alternative treatments, such as stem cell therapies, which do not focus on the viral aspect of the disease. Amniotics’ stem cell therapy product PulmoStem™ is not limited solely to virally induced inflammation in lung tissue. PulmoStem is expected to stop the inflammatory process and facilitate regeneration of damaged lung tissue, regardless of cause. It therefore has the potential to be useful in a variety of different respiratory indications.

Amniotics’ planned Phase I/II study in hospitalized COVID-19 patients is a first-in-human clinical trial to investigate the safety and tolerability of intravenous (IV) dosing at different doses of PulmoStem in patients with moderate to severe COVID-19. We received approval for the study from the regulatory authorities in the UK and Sweden in early April. The approval in Sweden is conditional and requires an update to the application prior to initiating the study. In all, 9-18 hospitalized patients will be included in the study, which will also have secondary and exploratory endpoints related to lung regeneration effects, inflammatory response biomarkers and other clinical efficacy outcomes. We are now working diligently on the preparations for the study and expect to recruit the first patient during the summer.

Thanks to the Vinnova grant received at the beginning of the year of almost SEK 5 million, Professor Sandra Lindstedt at Skåne University Hospital in Lund is preparing the start of a clinical trial together with Amniotics in which stem cell therapy will be used to repair damaged discarded donor lungs so that they become useful for lung transplantation. Results were recently presented from a preclinical lung transplant study conducted by Professor Lindstedt’s group at Lund University and Skåne University Hospital. The study shows support for this concept and that treatment with PulmoStem significantly reduces the incidence of lung damage in connection with lung transplantation. The damaged lungs recovered following treatment with PulmoStem. The data also show a reduction in the incidence of Primary Graft Dysfunction (PGD), a serious transplant-related complication, while severe lung damage continued in untreated lungs. The effects of the lung transplant study were presented at the International Society for Heart and Lung Transplantation (ISHLT) 42nd Annual Meeting & Scientific Sessions, which was held April 27-30 in Boston, Massachusetts, USA. These important data pave the way for future studies. Lung transplantation is currently the only treatment for patients with severe end-stage lung disease.

At the beginning of the quarter, Amniotics co-founder Niels-Bjarne Woods and his research group at Lund University's stem cell center published an article in EMBO Reports describing a novel mechanism of generating specific
“Amniotics’ cutting-edge project will soon enter clinical trials. Shortly after the end of the quarter, we received the green light to initiate the Phase I/II clinical trial using our unique drug candidate PulmoStem™ to heal lung damage. After the end of the quarter, new preclinical data were also presented demonstrating that PulmoStem reduces the incidence of lung damage in connection with lung transplantation.”

blood cells, which may form the basis for novel treatment modalities for some of the most severe types of cancers. The study findings show that metabolic regulators can be used to direct blood development to produce cells such as Natural Killer (NK) cells and hematopoietic stem cells. We are now investigating how we can use and further develop this technology in our anti-cancer platform by generating standardized NK cells to attack and eliminate cancer cells. The results could ultimately address a great need in cancer care today.

We continue to see strong interest in engaging Amniotics as a contract manufacturer, and a collaboration would of course be an important addition to the funding of our clinical development program and our operational activities. To advance the company further in 2022, in April we chose to take out a short-term loan of SEK 15 million. We are currently evaluating various options for strengthening our financial position and securing the continued clinical development program.

In summary, we continue to deliver on our strategy. Amniotics’ vision is to develop life-changing treatments and we are convinced that our unique drug candidate PulmoStem has the potential to improve life for people who suffer from serious pulmonary diseases. We are now extremely close to the next important milestone for Amniotics — starting the first clinical trial with a focus on COVID-19/ARDS.

Lund, May 2022
Kåre Engkilde, CEO

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