CytoTools starts phase III study of DermaPro in Europe

- Study start in Germany in October and in up to seven other countries in the coming months
- High prospects of success after approval and market launch in India
- Sale of treasury shares generates extraordinary profit of EUR 0.33 million and creates additional financial leeway

Darmstadt, 29 October 2020 - The Management Board of CytoTools AG (ISIN DE000A0KFRJ1), a biotechnology holding company specializing in pharmaceutical and medical products, has started the phase III clinical study for the approval of its wound healing product DermaPro in Europe as announced. After the study design has already been approved by the European Medicines Agency (EMA), the study is expected to begin in the respective countries following approval by the relevant state authorities, such as the Federal Institute for Drugs and Medical Devices (BfArM).

The study design, which has been agreed with the EMA, plans to test the active ingredient DPOCL contained in DermaPro for complete wound closure in up to 400 test persons in a treatment period of no more than 12 weeks. Recruitment will initially start in Germany and will be extended to up to seven other countries in the coming months. "The comparatively low number of necessary test persons can be explained by the significantly increased healing success of DPOCL compared to the best alternative medication", explains Dr. Dirk Kaiser, Director of Research & Development at CytoTools AG. "This was over 76 percent in all groups of test persons in the Indian phase III study. And this even under the condition of complete wound closure". The treatment results of the European study will be compared to the treatment with wound dressings with physiological saline solution according to the specifications of the EMA.

According to the current milestone planning of the European Phase III study, the Company expects the study to be completed in the fourth quarter of 2022. One year earlier, in the fourth quarter of 2021, the Company expects interim results from the study. "Already at this point it will become apparent how well our European volunteers respond to DPOCL", says Dr. Mark-Andre Freyberg, CEO of CytoTools. "From this point on we also plan to enter into negotiations with interested pharmaceutical companies regarding the sale of DermaPro. We are expecting a great deal of interest here, as diabetes and therefore also the diabetic foot is still one of the most frequently occurring diseases of civilization worldwide".

Accordingly, the Company assesses the market potential of DermaPro unchanged as high. Around 470 million people worldwide currently suffer from a form of diabetes. In its Diabetes Atlas 2019, the International Diabetes Federation assumes that this number will increase to around 580 million people by 2030. Around 10 to 15 percent of all diabetics also develop the diabetic foot syndrome at least once during the course of their disease. "Treatment of the diabetic foot with DermaPro takes between four and twelve weeks, depending on the severity of the symptoms," explains Dr. Mark-Andre Freyberg. "With DermaPro we are making a therapy available to this group of patients which has been proven to promise significantly higher chances of a cure than the therapies currently available on the market".

The company has already fully secured the financing of the study through a cash capital increase carried out in August. In addition, the company has gradually disposed of a total of 159,000 of own treasury shares via the stock exchange in recent weeks. The shares were acquired in 2019 in order to be able to service an outstanding convertible bond. Now that the bond has already been fully converted, the treasury shares are no longer required. The sale of the treasury shares generated an extraordinary profit of EUR 0.33 million, which now gives the Company further financial leeway in its operating business.

Further information on CytoTools AG, its affiliated subsidiaries and the active substance pipeline of the holding company is available on the company website at

Contact:
CytoTools AG
Ingo Middelmenne
Investor Relations
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About CytoTools:

CytoTools AG is a German biotechnology holding company which translates results from basic cell biological research on cell growth and programmed cell death into new forms of therapy for the causal treatment of disease and healing. CytoTools' versatile product pipeline includes self-developed chemical compounds and biopharmaceuticals which have the potential to offer new treatment options in dermatology, cardiology, urology and oncology. CytoTools is structured as a technology holding and investment company and has holdings in the subsidiaries DermaTools Biotech GmbH (62 %) and CytoPharma GmbH (50 %).

Disclaimer
This release contains certain forward-looking statements. These reflect the opinion of CytoTools as of the date of this release. The results actually achieved by CytoTools may differ considerably from the statements made in the future-oriented statements. CytoTools is not obliged to update forward-looking statements.