Vivoryon Therapeutics N.V. Q1 2024 Financial Results and Kidney Disease Strategy Update

Vivoryon Therapeutics, a clinical-stage biotechnology company, released its financial results for the first quarter of 2024, ending March 31, 2024. The company also provided updates on its strategic direction and research developments, particularly its new focus on inflammatory and fibrotic diseases, with a strong emphasis on kidney disease.

Financial Overview

In the first quarter of 2024, Vivoryon reported no revenues, similar to the same period in 2023. Research and development expenses increased significantly to EUR 7.4 million, up from EUR 3.1 million in the same period last year. This rise was mainly due to the clinical development costs associated with the VIVIAD and VIVA-MIND studies. General and administrative expenses also saw a modest increase, reaching EUR 2.1 million compared to EUR 1.9 million in the first quarter of 2023. Consequently, the net loss for the quarter was EUR 9.3 million, up from EUR 5.1 million in the previous year. As of March 31, 2024, Vivoryon held EUR 22.0 million in cash and cash equivalents, down from EUR 28.6 million as of December 31, 2023.

Strategic Shift to Kidney Disease

Vivoryon has decided to shift its strategic focus toward inflammatory and fibrotic diseases, especially those affecting kidney function. This decision follows the disappointing results from the VIVIAD Phase 2b study in early Alzheimer's disease (AD), which did not meet its primary and key secondary endpoints. However, the study revealed a significant positive effect of varoglutamstat, Vivoryon's lead candidate, on kidney function. This finding has driven the company to explore varoglutamstat’s potential in treating chronic kidney disease (CKD) and other rare diseases that impact kidney health.

Varoglutamstat’s Role in Kidney Disease

Further analyses have shown that varoglutamstat significantly improves estimated glomerular filtration rate (eGFR), a critical measure of kidney function. This effect was consistent across various sensitivity and subgroup analyses. Patients with risk factors for CKD, such as diabetes and hypertension, also showed improvements. The beneficial impact of varoglutamstat was observed across different baseline eGFR impairment levels, using various methods to calculate kidney function. Additionally, varoglutamstat demonstrated a significant and dose-dependent reduction in the pro-inflammatory cytokine pE-CCL2, indicating its anti-inflammatory effect.

Alzheimer's Disease Update

Despite the positive kidney function results, varoglutamstat did not show a consistent effect on cognition in patients with early AD, even in those with higher drug exposure. The VIVA-MIND study's topline results, expected by the end of 2024, will provide further insights and inform the next steps in varoglutamstat’s development strategy for AD.

Early-Stage Pipeline and Corporate Developments

Vivoryon continues to develop its early-stage pipeline, focusing on pre-clinical QPCT/L inhibitors for various indications, including oncology and Central Nervous System (CNS) disorders. The company's antibody program, PBD-C06, remains active for potential partnering opportunities. Corporate changes included the resignation of Kugan Sathiyanandarajah and Professor Dr. Morten Asser Karsdal from the Board of Directors in March 2024 and the appointment of Anne Doering, CFA, as Chief Financial Officer.

Outlook and Financial Guidance

Vivoryon expects its existing cash and cash equivalents to fund operations into the second quarter of 2025, considering the new strategic focus on kidney disease and the reduction in spending on AD-related studies. The company acknowledges the necessity of raising additional funds to ensure long-term viability and success in its research and development activities.

Conclusion

Vivoryon Therapeutics has pivoted its strategic focus towards kidney disease, driven by promising results from varoglutamstat. The company remains committed to advancing its clinical programs and exploring potential business development opportunities to support its new direction.

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