Amniotics AB (publ) Report for the second Quarter 2023
August 31, 2023
Positive topline study results and key patent approved April – June in brief
- Total revenues: SEK 0 (0).
- Operating profit (EBITDA): SEK -6.0 (-10.2) million.
- Result for the period: SEK -6.5 (-10.7) million.
- Earnings per share: SEK -0.03 (-1.11).
- Cash flow for the quarter: SEK -34.5 (-3.6) million.
- Cash and cash equivalents at the end of the reporting period: SEK 5.8 (29.1) million.
- Equity/assets ratio as per the end of the reporting period: 34 (65) %.
- The Annual General Meeting held on 22 May 2023, re-elected 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.
- As previously communicated, the company has during this quarter, paid out 25.3 MSEK of the EU-Pathfinder grant to the other consortium participants.
- Amniotics were able to present that the primary endpoint for the PulmoStem Phase I study was achieved, i.e., 100% survival and that no predefined complications occurred.
- 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.
Significant events after the end of the reporting period
- 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) 4,8 MSEK.
- The Board of Directors of Amniotics resolved on August 31, 2023, subject to subsequent approval at the Extraordinary General Meeting on October 3, 2023, to carry out an issue of not more than 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 issue is secured to 80 percent through subscription intentions, subscription undertakings and guarantee commitments. Upon full exercise of the warrants, Amniotics may receive an additional maximum of approximately SEK 25 million before issue costs.
Positive topline study results and key patent approved
During the quarter, Amniotics was able to present that the primary endpoint for the PulmoStem Phase I study was achieved, i.e., 100% survival and that no predefined complications occurred. This paves the way for continued development of PulmoStem, where the focus is to improve the outcome of lung transplants. This area is of high medical interest, as the average survival after lung transplantation is only approx. 6 years. Thus, the medical need in this area of medicine, where measures to protect the organ and the patient through cell therapy seem particularly urgent. The company was also granted a key patent in the EU for the company's technology platform for neonatal cell production and use, including PulmoStem, which is valid until at least 2040. The company has continued product optimization and regulatory work ahead of continued clinical trials of PulmoStem.
In June, the outcome of the warrant program TO2 was announced, where it was gratifying that the subscription rate was over 90%. Unfortunately, the subscription price was significantly lower than previous forecasts indicated, and the company therefore urgently needs to attract new capital. The market situation has not improved compared to the previous quarter, but our hope is that our shareholders will continue to support the company. Our savings program will take full effect from October 2023, and we can continue to deliver value increase at a significantly lower cost in this new organization.
Promising data regarding our product candidate CogniStem was presented in June at an international stem cell symposium. We were able to show that these cells were selectively enriched in the brain linked to improvement of sensory functions in a model system. This is indicative that the cells pass the blood-brain barrier. The company sees this as a very promising result, which means that we will accelerate this pre-clinical research program where the target diagnoses are the degenerative brain diseases Parkinson's, Alzheimer's and ALS.
The company has also increased its focus on contract manufacturing in the company's GMP plant as a future source of revenue. As previously communicated, the company's strategy is to establish strategic partnerships to help bear development costs, especially in later stages of clinical development, and this work continues.
Lund, August 2023
For more information please contact
CEO, Amniotics AB
Phone: +46 (0) 763 0840 91
Amniotics AB (publ) is a clinical stage biotech company, developing innovative therapies, based on amniotic fluid derived stem cells. The company develops therapies to treat diseases where effective treatments are currently lacking.
Amniotics has an established GMP-facility, approved and licensed by the Swedish Medical Products Agency. The company has capabilities as a Contract Development and Manufacturing Organization (CDMO) for other biotech companies.
Amniotics is headquartered in Lund, Sweden.
The company is listed at Nasdaq First North Growth Market in Stockholm. Amniotics Certified Adviser at First North is Redeye AB.
Learn more at www.amniotics.com.