On 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, reported financial results for the first six months of 2021 and provided an update on clinical and corporate progress (Press release, Vivoryon Therapeutics, SEP 21, 2021, View Source [SID1234588088]).
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"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 initiated as planned. VIVA-MIND is a combined Phase 2a/b study expecting to enroll 180 patients into the Phase 2a adaptive dose finding part, with an interim futility analysis planned for H1/2023. If predefined criteria are fulfilled, the trial is stage-gated into the Phase 2b part, enrolling an additional 234 patients treated at the selected dose for ³72 weeks. The primary endpoint for this study is CDR-SB (clinical dementia rating scale – sum of boxes), an established approvable endpoint measuring a combination of cognitive abilities and activities of daily living. The VIVA-MIND study is sponsored by Vivoryon and the study director is Dr. Howard Feldman, Professor of Neurosciences and Director of the Alzheimer’s Disease Cooperative Study (ADCS) at the University of California San Diego School of Medicine. The study is coordinated by the ADCS, and supported by the National Institute on Aging (NIA), part of the National Institutes of Health (NIH) (NIA award number R01AG061146). The study’s first site is now approved to initiate screening of its first participant.
On June 29, 2021, Vivoryon and Simcere Pharmaceutical Group Ltd announced that they have entered into a strategic regional licensing partnership to develop and commercialize medicines targeting the neurotoxic amyloid species N3pE (pGlu-Abeta) to treat AD in Greater China. The agreement grants Simcere a regional license to develop and commercialize varoglutamstat (PQ912), Vivoryon’s Phase 2b-stage N3pE amyloid-targeting oral small molecule glutaminyl cyclase (QPCT) inhibitor with disease-modifying potential for AD, as well as the Company’s preclinical monoclonal 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 study centers were opened to balance the effects of COVID-19 related patient and staff protection policies implemented at German 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 (View Source).
Patent Portfolio
Throughout the first half of 2021, Vivoryon has significantly expanded its patent portfolio with eight additional patents granted for the Company’s small molecule inhibitors and antibody-based medicines in development to treat AD and other diseases with exceptionally high medical need. Year to date (as of September 21, 2021) a total 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 presented for resolution by the Board of Directors were approved with a large majority and can be found on the Company’s website.
On April 15, 2021, Vivoryon hosted a virtual event covering next steps in AD treatment options with leaders and experts in the field. The interactive session covered discussions surrounding current hurdles and exciting, novel approaches to the challenging AD space, including varoglutamstat, the Company’s small molecule inhibitor 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 from InflaRx, 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 and Public Accountant at Arthur Andersen and Ernst & Young. Mr. Schmid holds a business degree from the Ludwig‐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 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.