DGAP-News: Vivoryon Therapeutics N.V. / Key word(s): Half Year Results Vivoryon Therapeutics N.V.: Vivoryon Therapeutics N.V. Reports H1 2021 Financial Results and Operational Progress (news with additional features) 2021-09-21 / 07:00 The issuer is solely responsible for the content of this announcement.

-----------------------------------------------------------------------------------------------------------------------

Vivoryon Therapeutics N.V. Reports H1 2021 Financial Results and Operational Progress . Strategic regional licensing partnership with Simcere Pharmaceutical Group to treat AD in Greater China . US Phase 2 VIVA-MIND study for varoglutamstat in AD initiated as planned . Conference call and webcast scheduled for September 21, 2021 at 3:00 pm CEST / 9:00 am EDT

Halle (Saale) / Munich, Germany, September 21, 2021 - Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, today reported financial results for the first six months of 2021 and provided an update on clinical and corporate progress. "In the first half of 2021, we made significant progress towards bringing our lead candidate varoglutamstat to patients suffering from Alzheimer's disease. Despite the ongoing pandemic, recruiting into our European Phase 2b study VIVIAD is on track and we're particularly excited about the initiation of our complementary Phase 2 study VIVA-MIND in the US. Furthermore, by entering into a strategic regional partnership with Simcere, we have made substantial headway towards making varoglutamstat available to AD patients in China in the future," said Dr. Ulrich Dauer, CEO of Vivoryon. "Beyond AD, we are pleased to see our diverse preclinical pipeline of oral small molecule inhibitors maturing in a number of indications with exceptionally high medical need."

Corporate Highlights and R&D Updates Varoglutamstat . Vivoryon's US Phase 2a/b VIVA-MIND study for varoglutamstat in patients with early AD is being initiatedas planned. VIVA-MIND is a combined Phase 2a/b study expecting to enroll 180 patients into the Phase 2a adaptivedose finding part, with an interim futility analysis planned for H1/2023. If predefined criteria are fulfilled, thetrial is stage-gated into the Phase 2b part, enrolling an additional 234 patients treated at the selected dose for>=72 weeks. The primary endpoint for this study is CDR-SB (clinical dementia rating scale - sum of boxes), anestablished approvable endpoint measuring a combination of cognitive abilities and activities of daily living. TheVIVA-MIND study is sponsored by Vivoryon and the study director is Dr. Howard Feldman, Professor of Neurosciencesand Director of the Alzheimer's Disease Cooperative Study (ADCS) at the University of California San Diego Schoolof Medicine. The study is coordinated by the ADCS, and supported by the National Institute on Aging (NIA), part ofthe National Institutes of Health (NIH) (NIA award number R01AG061146). The study's first site is now approved toinitiate screening of its first participant. . On June 29, 2021, Vivoryon and Simcere Pharmaceutical Group Ltd announced that they have entered into astrategic regional licensing partnership to develop and commercialize medicines targeting the neurotoxic amyloidspecies N3pE (pGlu-Abeta) to treat AD in Greater China. The agreement grants Simcere a regional license to developand commercialize varoglutamstat (PQ912), Vivoryon's Phase 2b-stage N3pE amyloid-targeting oral small moleculeglutaminyl cyclase (QPCT) inhibitor with disease-modifying potential for AD, as well as the Company's preclinicalmonoclonal N3pE-antibody PBD-C06 in the Greater China region. . Enrollment into the ongoing European Phase 2b VIVIAD study in patients with mild cognitive impairment(MCI) and mild AD is on track, with an interim safety readout anticipated in mid-2022. A number of additional studycenters were opened to balance the effects of COVID-19 related patient and staff protection policies implemented atGerman study sites. Details on the study led by Prof. Dr. Philip Scheltens, University Medical Center, Amsterdam,were recently published in a peer-reviewed journal as Vijverberg et al., Alzheimer's Research & Therapy (2021)13:142 (https://doi.org/10.1186/s13195-021-00882-9). Patent Portfolio . Throughout the first half of 2021, Vivoryon has significantly expanded its patent portfolio with eightadditional patents granted for the Company's small molecule inhibitors and antibody-based medicines in developmentto treat AD and other diseases with exceptionally high medical need. Year to date (as of September 21, 2021) atotal of 14 additional patents have been granted.

Corporate Developments . On June 28, 2021, Vivoryon held its 2021 Annual General Meeting as a virtual event. All items presentedfor resolution by the Board of Directors were approved with a large majority and can be found on the Company'swebsite. . On April 15, 2021, Vivoryon hosted a virtual event covering next steps in AD treatment options withleaders and experts in the field. The interactive session covered discussions surrounding current hurdles andexciting, novel approaches to the challenging AD space, including varoglutamstat, the Company's small moleculeinhibitor of QPCT designed to target all three hallmarks of AD: amyloid-beta, tau, and neuroinflammation. . On April 1, 2021, Florian Schmid joined Vivoryon as Chief Financial Officer. He joined the Company fromInflaRx, where he served as Director Finance & Controlling. Prior to Vivoryon Mr. Schmid led the Global Deal &Business Support department at T-Systems International GmbH. He began his career as certified Tax Advisor andPublic Accountant at Arthur Andersen and Ernst & Young. Mr. Schmid holds a business degree from theLudwig-Maximilian-University, Munich. Financial Results for the First Six Months of 2021 In the first two quarters of 2021, research and development expenses amounted to EUR 9,456 k (H1 2020: EUR 6,380 k). This increase was mainly driven by higher expenses for production (H1 2021: EUR 4,194 k, H1 2020: EUR 1,876 k), expenses for share-based payments (H1 2021: EUR 464 k, H1 2020: EUR 3 k) and higher costs associated with basic research projects in connection with Meprin (H1 2021: EUR 220 k, H1 2020: nil) and cancer (H1 2021: EUR 162 k, H1 2020: nil). General and administrative expenses increased to EUR 2,337 k (H1 2020: EUR 1,138 k). This increase is largely attributable to costs for consulting (H1 2021: EUR 1,030 k, H1 2020: EUR 481 k) and expenses for share based payments (2021: EUR 464 k, 2020: nil). The increase in consulting costs resulted from the transformation of the Company's legal form, subsequent adaption of administrative structures and preparations for potential future capital measures. The Company did not generate any licensing revenues in the reporting period. Revenues deriving from the strategic regional licensing partnership with Simcere will be recognized starting in the third quarter of 2021. Net loss of the period was EUR 11,671 k compared to EUR 7,572 k in the first half of 2020. The Company held EUR 19,832 k in cash and cash equivalents as of June 30, 2021, compared to EUR 26,306 k as of December 31, 2020. Conference Call and Webcast Vivoryon will host a conference call and webcast today, September 21, 2021, at 3:00 pm CEST / 9:00 am EDT. A Q&A session will follow the presentation of the half year results. Please dial one of the following access numbers: From Germany: +49 69 201 744 220 From The Netherlands: +31 207 168 020 From UK: +44 20 30 092 470 From the US: +18 774 230 830 PIN Code: 53651371# Please dial in ten minutes prior to commencement. A live webcast and slides will be made available at: www.vivoryon.com/investors-news/news-and-events/ presentations-webcasts/. Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/. The statement for the first six months of 2021 is available on the Company's website www.vivoryon.com/investors-news/ financial-information. Vivoryon Therapeutics N.V. Condensed Statements of Profit or Loss and Other Comprehensive Income


                                                             For the six months ended June 30, 
(in EUR thousand, except for share data)                           2021             2020 
 
Operating Expenses 
Research and development expenses                                       9,456            6,380 
General and administrative expenses                                     2,337            1,138 
Total Operating Expenses                                               11,793            7,518 
Other income                                                              (5)             (38) 
Operating loss                                                         11,788            7,480 
Finance income                                                          (219)                - 
Finance expenses                                                          102               92 
Finance result                                                          (117)               92 
Loss for the Period                                                    11,671            7,572 
 
Share Information 
Weighted average number of shares outstanding                      19,975,482       19,975,482 
Loss per share (basic/diluted)                                         (0.58)           (0.38) 
 
Loss for the Period                                                    11,671            7,572 
Items not to be reclassified subsequently to profit or loss: 
Remeasurement of the net defined benefit pension liability                  -               20 
Total Comprehensive Loss                                               11,671            7,592 
 Vivoryon Therapeutics N.V. Condensed Statements of Financial Position 
                                      June 30, December 31, 

(MORE TO FOLLOW) Dow Jones Newswires

September 21, 2021 01:00 ET (05:00 GMT)