DGAP-News: Biotest AG: Biotest accelerates trimodulin development in hospitalized COVID-19 patients with federal funding in the volume of 29 million EUR

PRESS RELEASE

Biotest accelerates trimodulin development in hospitalized COVID-19 patients with federal funding in the volume of 29 million EUR

- The German Federal Ministry of Education and Research (BMBF) and German Federal Ministry of Health (BMG) awarded Biotest's trimodulin project with financial support in the volume of €29 million

- The funding allows Biotest to speed up its activities in manufacturing and clinical development of trimodulin

- The Paul-Ehrlich-Institut (PEI) recommended to continue the clinical development in the proposed phase III trial in COVID-19.

- Biotest is committed to contribute to the fight against COVID-19

Dreieich, 23 November 2021. The German Ministries of Health, and Education & Research announced today (German press release), that they grant Biotest financial support for its COVID-19 therapeutic. The total funding of €29 million will support the phase III clinical development of trimodulin for the treatment of hospitalized patients with COVID-19.

With this grant the German Government supports the manufacturing and clinical development of promising therapies against COVID-19, which are already in late stage development. In the previous multinational phase II clinical trial (ESsCOVID) Biotest identified a patient population with COVID-19 that markedly benefited from treatment with trimodulin compared to placebo treated patients.

The Paul-Ehrlich-Institut (PEI) agreed to continue the clinical development of trimodulin in a phase III trial in the selected target population of patients with COVID-19 receiving oxygen support.

"We are deeply grateful for the public financial support of our trimodulin project in COVID-19. The funding will enable us to speed up the clinical development and the preparation for trimodulin manufacturing for the large scale supply", stated Dr Georg Floß, Chief Operations Officer at Biotest.

"We are very pleased to have recently identified a population of hospitalized COVID-19 patients with early systemic inflammation that benefited from trimodulin treatment in the previous phase II trial. With the agreement from the German Regulatory Authority (PEI) on the proposed design of the planned phase III trial and the grant by the BMG and BMBF we look forward to continue clinical development in this crucial disease area", said Dr Thomas Häder, responsible Head of Clinical Strategy & Development at Biotest Corporate Clinical Research and Development.

About COVID-19
COVID-19 is a respiratory disease caused by the novel severe acute respiratory syndrome corona virus 2 variant (SARS-CoV-2). While most cases are mild or asymptomatic, COVID-19 patients may present at the hospital with typical signs of pneumonia requiring oxygen support. This disease stage is regularly accompanied by an excessive immune response and can lead to systemic inflammation reactions. Furthermore, patients may progress to critical disease with advanced systemic inflammation and with need for intensive care, including invasive mechanical ventilation.

About trimodulin (IgM Concentrate)
Trimodulin is an innovative polyvalent antibody composition, purified from human plasma. In comparison to standard IgG preparations (IVIG), trimodulin contains relevant amounts of IgM and IgA in addition to IgG. Trimodulin is currently in clinical development for the treatment of patients with severe community-acquired pneumonia (sCAP) and for patients with severe COVID-19. Research so far has shown that trimodulin could interfere with a number of mechanisms involved in pathological processes that would otherwise lead to respiratory failure, sepsis, multi-organ failure and finally to death of the patient. Due to the large variety of polyvalent antibodies present in trimodulin, the impaired immune system is supported in various ways. Particularly the IgM component in trimodulin can reduce dysregulated immune responses, preventing the immune system to attack host tissues, in this case the lung. The polyvalent antibodies also bind to various types of pathogens including viruses and bacteria as well as their toxins and support their clearance by the immune system. In this way, trimodulin may prevent progression of disease, including the need for invasive mechanical ventilation and other intensive care procedures.

About Biotest
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 1,900 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

IR contact
Dr Monika Buttkereit
Phone: +49-6103-801-4406
Mail: investor_relations@biotest.de

PR contact
Dirk Neumüller
Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
Listing: Frankfurt (Prime Standard)
Open Market: Berlin, Düsseldorf, Hamburg/ Hanover, Munich, Stuttgart, Tradegate

Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.