On November 26, 2020 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY; ISIN DE0007921835) reported its third quarter business update for the period ending September 30, 2020 (Press release, Vivoryon Therapeutics, NOV 26, 2020, View Source [SID1234571781]). The third quarter 2020 report is available for download on the Company website (View Source).
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KEY HIGHLIGHTS
Enrollment of first patient in VIVIAD, the Company’s European Phase 2b Alzheimer’s disease study evaluating varoglutamstat (PQ912)
Announcement of IND approval for varoglutamstat (PQ912)
Successful completion of the Ordinary General Meeting of Shareholders
CORPORATE REVIEW
Financial Review (According to IFRS)
In the third quarter of 2020, research and development expenses amounted to EUR 3,653k and increased compared to the third quarter of 2019 (EUR 1,196k). General and administrative expenses increased to EUR 1,051k (Q3 2019: EUR 768k). The Company did not generate any revenue in the reporting period, in line with corporate planning. Therefore, the net loss of the period was EUR 4,598k compared to EUR 1,935k in the third quarter of 2019.
Vivoryon Therapeutics held EUR 10.0 million in cash and cash equivalents as of September 30, 2020. In addition, the Company holds other securities in amount of EUR 19,967k which can be liquidated at any time.
All results are in line with management expectations.
OPERATIONAL REVIEW
Announcement of Enrollment of First Patient in VIVIAD, European Phase 2b Alzheimer’s Disease Study with Varoglutamstat (PQ912)
The Company announced that the first patient was enrolled in VIVIAD, a Phase 2b, randomized and multi-center clinical study in Europe. The study will evaluate the safety and efficacy of Vivoryon’s lead candidate, varoglutamstat (PQ912), in patients with Alzheimer’s disease .
IND Approval for Phase 2 Study of Varoglutamstat (PQ912) in Patients with Alzheimer’s Disease
The Company announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application for varoglutamstat (PQ912). FDA clearance of the IND will enable Vivoryon to initiate its U.S. Phase 2 clinical trial program for varoglutamstat (PQ912) in Alzheimer’s disease as planned.
Ordinary General Meeting of Shareholders of Vivoryon Therapeutics AG
The Company announced that its shareholders approved all resolutions proposed by the Company’s management and Supervisory Board at the Company’s Annual General Meeting which took place on Wednesday, September 30, 2020. This included the transfer of the statutory seat to Amsterdam, the Netherlands, leading to a conversion into a public company under the laws of the Netherlands.