DGAP-News: Vivoryon Therapeutics AG
/ Key word(s): Half Year Results
Vivoryon Therapeutics Reports Financial Results for H1 2020
- Conference call and webcast in English at 3:00 pm CEST / 09:00 am EDT
- Vivoryon and Nordic Bioscience collaboration
- Meprin protease inhibitors development program
HALLE (SAALE) / MUNICH, Germany, 27 August 2020 - Vivoryon Therapeutics AG (Euronext Amsterdam: VVY), today announced its financial results for the first six months of 2020 ending June 30. The full interim report is available on the company website: https://www.vivoryon.com/investors-news/financial-information
"Notwithstanding the global crisis, the first six months of 2020 have yielded positive outcomes for Vivoryon that have resulted in the advancement of our clinical programs, the expansion of our drug development portfolio and the continued validation from regulatory bodies including the U.S. Food and Drug Administration (FDA) and World Health Organization.
In January, we entered a research and development collaboration with Nordic Bioscience, which will serve as our CRO (Clinical Research Organization) for the Phase 2b VIVIAD trial. We look forward to benefitting from Nordic Bioscience's expertise in the development of blood-based biomarkers for the identification of specific patients that may benefit most from treatment with varoglutamstat (PQ912). The ability to select patients who have a greater chance of responding to varoglutamstat (PQ912) presents an opportunity for Vivoryon to transfer an already tested principle of precision medicine into Alzheimer's disease.
Along with the update on our European Phase 2b clinical study in March, we announced the clinical trial's name, 'VIVIAD,' derived from 'advancing disease-modifying treatment and non-invasive diagnostics of Alzheimer's disease.' The study will test the efficacy and safety of various doses of varoglutamstat (PQ912) in 250 early-stage Alzheimer's patients in a randomized, placebo-controlled study over the course of 48 to 96 weeks. Professor Dr. Scheltens, Director of the Alzheimer Center at the VU University Medical Center in Amsterdam, will act as the coordinating investigator of the study, which intends to use ten recruiting sites in Denmark, Germany and the Netherlands.
Our lead candidate, formerly known as PQ912, also received external recognition from the World Health Organization through its newly appointed and approved International Nonproprietary Name (INN), varoglutamstat (PQ912); we look forward to its development under this new name.
From a research and development perspective, during the first half of the year we extended our portfolio by acquiring patents from the Fraunhofer Institute for Cell Therapy and Immunology (IZI) for the further development of Meprin protease inhibitors which have the potential to not only target symptoms, but also treat a range of indications including acute and chronic kidney disease and multiple organ fibrosis. Together with the Fraunhofer Institute, we will collaborate to develop novel low-molecular Meprin inhibitors. As a company, it is our goal to identify opportunities that can leverage our expertise in translating basic research into marketable small molecule therapeutics and thereby strengthen our pipeline with the ultimate vision of delivering novel therapies to patients in need. On a similar note, although MorphoSys did not exercise the exclusive option to license our small molecule QPCTL inhibitors, we remain optimistic about collaborating with other leading oncology companies in order to leverage the strength and versatility of our small molecule therapeutics.
The second half of the year was marked with further positive developments for Vivoryon. In July, we announced the enrollment of the first patient in VIVIAD, the European Phase 2b Alzheimer's disease study with varoglutamstat (PQ912). The data read-out of the VIVIAD study is expected to be available in 2023. Later in the month, the FDA cleared Vivoryon's Investigational New Drug (IND) application for varoglutamstat (PQ912), which will enable the initiation of our U.S. Phase 2 clinical trial. The U.S. trial is projected to initiate mid-2021 with a final data readout in 2023.
Key Figures (according to IFRS)
Details of the Financial Results (according to IFRS)
The operating loss for first half of 2020 was increased by EUR 4,403k to EUR 7,480k (H1 2019: EUR 3,077k). This was mainly driven by higher research and development expenses of EUR 6,380k (H1 2019: EUR 1,862k). The general and administrative decreased slightly to EUR 1.138k (H1 2019: EUR 1,223k).
Consequently, net loss was increased to EUR 7,572k (H1 2019: EUR 3,091k).
The cash flows used in investing activities amount to EUR 31,501k mainly resulted from the purchase of other securities (EUR 19,999k) which can be liquidated at any time and from time deposits (EUR 10,929k) with a runtime of 6 months.
All results are in line with management expectations.
Vivoryon Therapeutics will host a conference call and webcast open to the public today, August 27, 2020, at 3:00 pm CEST / 09:00 am EDT; the presentation will also be available on the company website. The conference will be held in English. A question and answer session will follow the presentation of the half year results.
To participate in the conference call, please call one of the following numbers ten minutes prior to commencement.
A live webcast and slides will be made available at: www.vivoryon.com/investors-news/financial-information/
Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: www.vivoryon.com/investors-news/financial-information/
January to June 2020
|Vivoryon Therapeutics AG
|+49 (0)345 555 9900
|+49 (0)345 555 9901
|Regulated Unofficial Market in Berlin, Frankfurt, Munich, Stuttgart; Amsterdam
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|DGAP News Service