CytoTools : reports progress of DermaPro Phase III Study in Europe and provides operational status update (103.1 KiB)

CORPORATE NEWS

CytoTools Reports Progress of DermaPro® Phase III Study in Europe and Provides Operational Status Update

• Good progress in patient recruitment for Phase III study despite unforeseen delays due to COVID-19
• Sales of Woxheal® gaining significant momentum since September
• Further development steps of DPOCL inhalation therapy suspended as a precautionary measure to preserve cash position

Darmstadt, 29 September 2021 -CytoTools AG (ISIN DE000A0KFRJ1), a biotechnology holding company specializing in pharmaceutical and medical products, provides a status update on the progress of key development projects and the operational business development in advance of its virtual Annual General Meeting to be held tomorrow. Overall, it is evident that delaying effects due to COVID-19are gradually diminishing and an increasing normalization of the environment is perceptible in almost all areas.

The Phase III trial of DermaPro® in Europe, which started at the end of 2020, is progressing increasingly according to plan after a slow start. In the first half of 2021, it became apparent that numerous preparatory steps in the run-up to so-called patient recruitment were delayed, in some cases significantly, by COVID-19. For example, the approval of the German ethics committee was only available after a considerable delay, as the committee did not meet for several months against the background of COVID-19. Furthermore, travel restrictions - especially with regard to Eastern European countries - meant that necessary preparatory steps for the start of patient recruitment in Georgia and Latvia had to be postponed. In the meantime, however, recruitment has started in Georgia and Latvia and is about to start in Germany. All necessary arrangements have also been made for the studies applied for in Poland and Austria, although the final approval notice is still awaited.

The Company expects an average number of recruitable patients of 25 to 35 per month. Thus, the completion of the recruitment phase could still be achieved in Q4 2022 without further delays.

Sales of Woxheal®, the counterpart of DermaPro® approved by Centaur in India, were still significantly impacted by the severe course of COVID-19 in India. Active sales of the drug were very limited due to extensive travel restrictions. Nevertheless, sales figures improved from quarter to quarter, although overall they still fell short of expectations. However, in the wake of rising vaccination rates in India and an increasing normalization of the general situation, a significant increase in sales figures in India has been recorded since September. The licensing partner Centaur Pharmaceuticals is therefore confident that it will be able to further significantly increase sales figures in the further course of the year and in the coming year, in order to be able to make reliable statements on market penetration for the first time in the first half of 2022.

CORPORATE NEWS

In the development of an inhalation therapy using DPOCL as the active ingredient in the case of COVID-19 and influenza, the Company has, as planned, begun toxicological studies of the effects of inhalation administration of DPOCL as an aerosol within the organism. However, in view of the expected costs in the further course of the project and the uncertain financing situation due to the repeated foreseeable prevention of important financing measures by an activist group of investors, the Management Board has decided to wait with the further development steps in order to maintain the liquidity situation of the company until the conclusion of a necessary financing round. Since financing commitments have been received from new investors, the company expects to be able to resume project work in the foreseeable future after tomorrow's Annual General Meeting.

Further information on CytoTools AG, its affiliated subsidiaries and the holding company's drug pipeline is available on the company's website at www.cytotools.de.

Contact:

CytoTools AG

Ingo Middelmenne

Investor Relations

Mobile: +49-174-9091190

Email: middelmenne@cytotools.de

About CytoTools:

CytoTools AG is a German biotechnology holding company that translates results from basic cell biology research on cell growth and programmed cell death into novel therapies for causal disease treatment and cure. CytoTools' versatile product pipeline includes proprietary chemical compounds and biopharmaceuticals that have the potential to provide new treatment options in dermatology, cardiology, urology and oncology. CytoTools is structured as a technology holding and investment company and holds interests in its subsidiaries DermaTools Biotech GmbH (65%) and CytoPharma GmbH (50%).

Disclaimer

This release contains certain forward-looking statements. These reflect the views of CytoTools as of the date of this release. Actual results achieved by CytoTools may differ materially from the findings in the forward-looking statements. CytoTools is under no obligation to update any forward-looking statements.