On March 26, 2020 Vivoryon Therapeutics AG (Euronext Amsterdam: VVY; ISIN: DE007921835), reported its financial results for the twelve month period ending December 31, 2019, prepared in accordance with German GAAP ("HGB") and on a voluntary basis, in accordance with IFRS as endorsed by the European Union (Press release, Vivoryon Therapeutics, MAR 26, 2020, View Source [SID1234555877]). The Financial Statements are available on the company website (www.vivoryon.com/investors-news/financial-information/).
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KEY HIGHLIGHTS – January – December 2019
USD 15 million grant from National Institutes for Health (NIH) for a US-based Phase 2b trial received, together with the Alzheimer’s Disease Cooperative Study (ADCS)
EUR 8.2 million raised from investors in successful private placement of new shares in April 2019
Probiodrug AG became Vivoryon Therapeutics AG
Vivoryon entered into a collaboration with University of Kiel to select candidates from its QPCTL inhibitor portfolio
MorphoSys and Vivoryon entered an agreement on small molecule inhibitors of CD47-SIRP alpha signaling in immuno-oncology
Vivoryon successfully completed a EUR 43 million capital raise in October 2019
Vivoryon included in AScX index
POST PERIOD HIGHLIGHTS – January – March 2020
Vivoryon and Nordic Bioscience entered research and development collaboration
Vivoryon announced update on Phase 2b Alzheimer’s clinical trial, VIVIAD
Comment from, Dr. Ulrich Dauer, Chief Executive Officer of Vivoryon Therapeutics:
"2019 proved to be a pivotal year for Vivoryon during which the Company established itself with a new name and a re-energized corporate vision unified by the same goal: to discover and develop small molecule therapeutics to meet complex medical needs. During the past 12 months, Vivoryon has undergone a corporate transformation designed to build value for shareholders, patients and collaborators and that will ultimately steer the Company toward success. Equipped with a secure financial position, strong strategic partnerships and growing clinical knowledge, Vivoryon has entered 2020 with the momentum required to reach future milestones.
First, from a financial perspective, 2019 was an important year for the Company in which securing adequate funding was particularly critical for the advancement of PQ912 in Alzheimer’s Disease. At the start of the year, we received a USD 15 million grant from the NIH. After that, the Company raised EUR 8.2 million from investors in a successful private placement of new shares in April, followed by a EUR 43 million capital raise in October. These monetary developments fortify our fiscal well-being and place us in an optimal position to continue to advance our pipeline.
Based on our clinical development efforts in 2019, we are now reaching the final stages of preparation for the European Phase 2b clinical trial, VIVIAD, testing PQ912 in patients with early-stage Alzheimer’s Disease. In parallel, the funding from the NIH will be allocated to our US Phase 2b trial in Alzheimer’s which we aim to initiate as soon as the required financial resources have been secured. Our lead candidate, PQ912 is a first-in-class inhibitor of the QPCT enzyme that addresses a very distinct disease pathway and provides a mode of action affecting multiple pathology hallmarks in contrast to many other Alzheimer’s Disease drug candidates in development. Building on positive Phase 2a data, we aim to continue to validate our approach in this complex neurodegenerative disease and look forward to initiating VIVAD in Europe within the second quarter of 2020. We expect to announce the topline results of this important trial towards the end of 2022.
The preparation for the VIVIAD trial also involved two strategic relationships that add significant value to the trial design. We kicked-off the new year by announcing our research and development collaboration with Nordic Bioscience for the clinical development of PQ912 for Alzheimer’s Disease as well as for the development of blood-based biomarkers for the identification of specific patients that may benefit most from treatment with PQ912. We also entered into a collaboration with Winterlight Labs, a company that has developed a proprietary, tablet-based technology that assesses cognitive health (including memory, thinking, and reasoning) by analyzing hundreds of language markers from short snippets of speech. This collaboration will enable Vivoryon to perform an additional non-invasive, cognitive test on patients that will further enhance the full data package from the Phase 2b European VIVIAD clinical trial. Prof. Dr. Scheltens, VU Amsterdam will act as coordinating investigator for VIVIAD.
During last year, we also made rapid progress in the immuno-oncology space as illustrated by both the collaboration with the University of Kiel as well as our option-agreement with MorphoSys. The MorphoSys relationship combines our portfolio of proprietary small molecule QPCTL inhibitors with their leading antibody technology. Both collaborations underscore the potential of our therapeutic agents as well as our ability to forge meaningful and strategic partnerships to advance our pipeline.
In closing, 2019 was a defining year for Vivoryon. I therefore want to extend our thanks to our shareholders for all the support throughout our transformation as well as to the team at Vivoryon. 2020 will bring both new opportunities and challenges and together, we have the resources and the clear objective to positively change the lives of patients battling difficult-to-treat diseases."
Details of the Financial Results (according to IFRS)
Net loss
The operating loss slightly rose in 2019 to EUR 7,715 (2018: EUR 7,698k). Research and development expenses slightly decreased to EUR 4,751k (2018: EUR 4,836). General and administrative expenses increased to EUR 3,023k (2018: EUR 2,891k). The net loss is slightly higher than last year at EUR 7,823k (2018: EUR 7,737k).
All expenditures are in line with the projections of Vivoryon Therapeutics.
Equity
The equity as of December 31, 2019 amounts to EUR 42,665k (December 31, 2018: EUR 1,230k), corresponding to an equity ratio of 93,0 %. In 2019, the share capital increased at EUR 19,975k.
Cash
The cash flow used in investing activities amounted to EUR -47k (2018: EUR 460k) consisting of costs in intangible assets and equipment. Cash and cash equivalents at year end 2018 were EUR 41,524k (2018: EUR 3,783k).
Noncurrent/ current liabilities
As of December 31, 2019, non-current liabilities amounted to EUR 2,266k (December 31, 2018: EUR 1,854k) and consist of pension obligations of EUR 1,951k (2018: EUR 1,854k ) and long-term lease liabilities in accordance with IFRS 16, which was applicable for the first time in 2019 of EUR 315k. Short-term liabilities as of December 31, 2019 of EUR 930k remained almost the same as in the previous year (December 31, 2018 EUR 964k). Trade payables of EUR 539k (2018: EUR 772k) result from the normal course of business. They have a remaining term of up to one year. The short-term lease liabilities of EUR 91k reported for the first time on December 31 also result from the first-time application of the new IFRS 16.
OUTLOOK
The mid-term focus of Vivoryon’s business activities can be summarized as follows:
Initiate Phase 2b clinical study program for PQ912 in Europe
Continue the development of PQ912 in oncology
Conclude one or more industrial partnerships
Further scientific analysis of potential indications for the use of QC inhibitors
ANNUAL FINANCIAL REPORT 2019
Vivoryon Therapeutics has finalized its financial statements for the year ended December 31, 2019 according to German GAAP ("HGB") and IFRS. The auditor KPMG has issued an unqualified auditors report for both statements. The reports are available on the company website (View Source).
FINANCIAL CALENDAR
May 14, 2020 Interim Management Statement Q1 2020
June 24, 2020 Annual General Meeting 2020
August 27, 2020 Interim Report, Half Year Results 2020
November 26, 2020 Interim Management Statement Q3 2020
CONFERENCE CALL AND WEBCAST
Vivoryon Therapeutics will host a conference call and webcast open to the public today, March 26, 2020, at 3:00 pm CET (10:00 am EDT); the presentation will also be available on the company website. The conference will be held in English. A Question & Answer session will follow the presentation of results.
To participate in the conference call, please call one of the following numbers listed below 10 minutes prior to the commencement of the webcast.
A live webcast and slides will be made available at: View Source