On August 27, 2020 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY), reported its financial results for the first six months of 2020 ending June 30 (Press release, Vivoryon Therapeutics, AUG 27, 2020, View Source [SID1234564086]). The full interim report is available on the company website: View Source

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KEY HIGHLIGHTS
Vivoryon Therapeutics and Nordic Bioscience enter research and development collaboration
Initiation of development program for Meprin protease inhibitors with potential therapeutic use in fibrosis, cancer and Alzheimer’s disease
Announcement of outcome on exclusive option deal with MorphoSys
Update on U.S. and EU Alzheimer’s clinical trial program with varoglutamstat (PQ912)

POST PERIOD HIGHLIGHTS
Vivoryon Therapeutics enrolled first patient in VIVIAD, European Phase 2b Alzheimer’s disease study with varoglutamstat (PQ912)
Vivoryon Therapeutics announced IND approval for varoglutamstat (PQ912)

Comment from Dr. Ulrich Dauer, Chief Executive Officer of Vivoryon Therapeutics:

"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.

Despite the past months being marked by the Covid-19 pandemic and strict lockdown regulations, we are proud to have kept our entire workforce employed during this crisis. In order to provide a safe working environment, we provided flexible solutions to employees including working from home and in-office shifts. Business travel, which usually serves as an opportunity to network with potential investors and/or partners, was largely replaced by integrating a video conference system. Although we cannot predict how the second half of the year will progress from a global standpoint, as a company we are well-positioned to continue moving the Alzheimer’s clinical trials forward while exploring the potential of our unique proprietary position in cancer and fibrosis and identifying additional opportunities within our small molecule therapeutics pipeline. I would therefore like to extend a big thank you to all employees for their continued dedication and commitment as well as our shareholders who continue to support Vivoryon during these unprecedented circumstances."

Details of the Financial Results (according to IFRS)

Net loss

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).

Cash/Securities

Vivoryon Therapeutics held EUR 3,623k in cash and cash equivalents as of June 30, 2020 (Dec 31, 2019: EUR 41,524k).

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.

CONFERENCE CALL
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/

FINANCIAL STATEMENTS
January to June 2020

Vivoryon Therapeutics has finalized its financial statements for the first six months of 2020 according to German GAAP ("HGB") and IFRS. The reports are available on the company website (View Source/).

Financial calendar 2020

September 30, 2020 Ordinary General Shareholder Meeting

November 26, 2020 Interim Management Statement Q3 2020