Varoglutamstat – early Alzheimer’s disease (AD):
In recent weeks Vivoryon has continued its in-depth analysis of the VIVIAD data, following the March 4, 2024, and April 24, 2024, disclosures. While these analyses remain ongoing, findings to date continue to confirm there is no consistent effect of varoglutamstat up to 600mg BID on cognition and function, including in high exposure patients. Data from VIVA-MIND, anticipated by the end of 2024, is expected to contribute to the overall dataset informing varoglutamstat’s development strategy in AD.
Early-Stage Pipeline
Vivoryon’s main focus is on its clinical-stage activities, however it will continue to explore pre-clinical QPCT/L inhibitors for use in inflammatory and fibrotic disorders and other indications such as oncology and CNS as well as pre-clinical meprin inhibitors, in particular for fibrotic disorders, and QPCT/L inhibitors with good blood brain barrier penetration. The Company’s antibody program, PBD-C06, will remain active as a candidate for further potential partnering opportunities.
Corporate Development Updates
In March 2024, Kugan Sathiyanandarajah and Professor Dr. Morten Asser Karsdal stepped down from Vivoryon’s Board of Directors. They had been appointed as Non-Executive Directors in June 2023.
In March 2024, Anne Doering, CFA, assumed the role of Chief Financial Officer (CFO) of Vivoryon, following her previous position as Chief Strategy & Investor Relations Officer.
In May 2024, Vivoryon announced it will hold its 2024 Annual General Meeting on Friday, June 21, 2024, at 1:00 p.m. (CEST) in Amsterdam, the Netherlands. The full agenda and all relevant documents are available on the Company’s website (https://www.vivoryon.com/2024-annual-general-meeting/).
Financial Results for the First Quarter of 2024
Revenues were zero in the three months ended March 31, 2024, as well as in the three months ended March 31, 2023.
Research and development expenses increased by EUR 4.3 million to EUR 7.4 million in the three months ended March 31, 2024, compared to EUR 3.1 million in the three months ended March 31, 2023. This increase was largely attributable to the increase in clinical development costs from the VIVIAD and VIVA-MIND studies.
General and administrative expenses were EUR 2.1 million in the three months ended March 31, 2024, compared to EUR 1.9 million in the three months ended March 31, 2023. The increase of EUR 0.2 million was largely attributable to higher expenses for share-based payments as well as legal and consulting fees.
Net loss for the three months ended March 31, 2024, was EUR 9.3 million, compared to EUR 5.1 million for the three months ended March 31, 2023.
The Company held EUR 22.0 million in cash and cash equivalents as of March 31, 2024, compared to EUR 28.6 million, which includes cash and cash equivalents and financial assets, as of December 31, 2023.
Outlook & Financial Guidance
As published on April 24, 2024, the Company expects, on the basis of its most recent financial and business plan, that its existing cash and cash equivalents will be sufficient to fund its operating plans, excluding any additional financings, into the second quarter of 2025.
This cash runway guidance reflects the shift in focus of research and development resources towards inflammatory and fibrotic disorders, such as of the kidney, and an overall reduction in cash utilization including the ramp down of spending on VIVIAD as it approaches its conclusion, the discontinuation of VIVA-MIND, the discontinuation of VIVALONG preparation activities given the developments of VIVIAD and VIVA-MIND, as well as the streamlining of manufacturing costs and programs for API development.
The viability of the Company beyond the second quarter of 2025 is dependent on its ability to raise additional funds to finance its operations which also depends on the success of its research and development activities such as those focusing on exploring opportunities in kidney disease.