On November 4, 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 and the corporate update for the third quarter of 2021, ending September 30, 2021 (Press release, Vivoryon Therapeutics, NOV 4, 2021, View Source [SID1234594408]). The report is available on the Company’s website at www.vivoryon.com/investors-news/financial-information

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"Throughout the third quarter, we made significant progress towards filling the gap of safe, widely available effective disease-modifying therapies in Alzheimer’s disease. Both our newly initiated study VIVA-MIND in the U.S. and our ongoing European study VIVIAD are progressing steadily and we have implemented a number of measures to ensure that the Company is able to deliver on its objectives, including stringent clinical development beyond the currently ongoing studies," said Dr. Ulrich Dauer, CEO of Vivoryon.

Corporate Highlights and R&D Updates

Varoglutamstat

In August 2021, details on the study background and design of Vivoryon’s European Phase 2b study VIVIAD in patients with mild cognitive impairment and mild AD were published in the Journal "Alzheimer’s Research & Therapy" (Vijverberg et al., View Source). The study is enrolling patients as planned despite the ongoing global pandemic. To avoid delays in recruitment and as a reaction to COVID-19-related patient and staff protection policies implemented at German study sites, Vivoryon is in the process of increasing the overall number of study sites, aiming to more than double the originally planned number. VIVIAD remains on track for an interim safety readout in mid-22 and Vivoryon continues to anticipate final data in the second half of 2023.
In September 2021, Vivoryon initiated its U.S. Phase 2a/b VIVA-MIND study for varoglutamstat in patients with early AD. VIVA-MIND is a combined Phase 2a/b study which seeks 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 will pass a stage-gate into the Phase 2b part, enrolling an additional 234 patients treated at the selected dose for at least 72 weeks, with a total of 414 patients being treated on stable doses of varoglutamstat for 18 months. 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), with a US$15 million grant (NIA award number R01AG061146). The study is ongoing with two sites now approved to screen participants and a group of another seven sites having secured regulatory approval.
Patent Portfolio

In the third quarter of 2021, Vivoryon further expanded its patent portfolio. Year to date (as of October 31, 2021) a total of 16 additional patents have been 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.

Post-period Events

In October 2021, the Company announced that it has decided to expand its manufacturing capabilities for production of active pharmaceutical ingredient (API) by initiating a second line of manufacturing with an additional partner to ensure sustainable study drug supply with varoglutamstat for the VIVA-MIND U.S. study. This will increase the total number of manufacturing sites for varoglutamstat to three on two different continents, providing supply for VIVA-MIND beyond the ongoing Phase 2a adaptive dose finding part, as well as for potential future studies in other geographies, with the added benefit of increasing flexibility to react to global challenges such as the ongoing pandemic.
Also in October 2021, Vivoryon and its collaboration partners published data providing strong preclinical evidence of treatment with a combination of the Company’s small molecule QPCT/L inhibitor varoglutamstat and its N3pE amyloid-specific antibody PBD-C06 having an additive effect on reducing brain Abeta pathology in transgenic mice. The data, published in the "International Journal of Molecular Sciences" (Hoffmann et al., View Source), support the hypothesis of a potential benefit of a combination therapy designed to simultaneously target two different and independent molecular pathways, namely reducing N3pE amyloid production by QPCT/L inhibition and clearing existing Abeta deposits through anti-N3pE-immunotherapy. This provides a strong rationale for the evaluation of therapies combining varoglutamstat with monoclonal antibodies to treat AD.
Financial Results for Q3 of 2021

In Q3, the Company generated license revenues of EUR 10.8 million from a strategic regional licensing partnership signed with its partner Simcere on June 29, 2021 for Greater China. No revenues were generated in 2020, respectively.

Research and development expenses incurred for the nine months ended September 30, 2021 increased over the corresponding period in 2020 by EUR 3.6 million. This increase was mainly driven by EUR 2.9 million higher expenses for production and Vivoryon’s clinical studies, as well as EUR 0.7 million higher expenses for share-based payments.

General and administrative expenses increased by EUR 1.2 million for the nine months ended September 30, 2021. This increase is largely attributable to EUR 0.3 million higher consulting costs and EUR 0.7 million higher expenses for share based payments. The increase in consulting costs resulted from preparations for a potential future listing on Nasdaq.

Net loss for the nine months ended September 30, 2021 was EUR 7.3 million, compared to EUR 12.2 million for the nine months ended September 30, 2020. The Company held EUR 19.9 million in cash and cash equivalents as of September 30, 2021, compared to EUR 26.3 million as of December 31, 2020.

Financial Guidance

On October 18, 2021, Vivoryon updated its financial guidance to account for costs associated with the expansion of its manufacturing capabilities for production of active pharmaceutical ingredient (API) by initiating a second line of manufacturing with an additional partner to ensure sustainable study drug supply with varoglutamstat for the VIVA-MIND U.S. study. According to current planning and estimates, the Company now expects a cash reach until mid-2022. A detailed update on anticipated working capital requirements and associated potential financing activities as well as resulting timelines will be given in the context of Vivoryon’s regular filings.

Unaudited Condensed Interim Financial Statements

Vivoryon Therapeutics N.V.

Condensed Statements of Operations and Comprehensive Income and Loss