Vivoryon Therapeutics: A Gamble on Kidneys or a Breakthrough in the Making?

Vivoryon Therapeutics (VIV:BR) has undergone a seismic shift in strategy, abandoning its once-promising Alzheimer’s drug pipeline to double down on kidney disease. After its star candidate varoglutamstat failed in late-stage trials for Alzheimer’s, the company pivoted aggressively in 2024—focusing on data showing the drug’s surprising benefits in diabetic kidney disease (DKD). This high-stakes pivot could either be a lifeline or a last-ditch gamble. Let’s break down the numbers, the science, and the risks.

Financials: Cutting Costs, Running on Fumes

The numbers are stark. Vivoryon reported a narrowed net loss of €20.6 million in 2024, down from €28.3 million in 2023, thanks to slashed R&D and administrative costs. But cash reserves have dwindled to just €9.4 million as of December 2024—a 49% drop from 2023. The company claims its current cash will last until early 2026, assuming it doesn’t tap its Standby Equity Purchase Agreement (SEPA) with Yorkville Advisors, which allows up to €15 million in funding over three years.

The Science: A Silver Lining in Failed Trials

The real story here isn’t the Alzheimer’s failure—it’s what Vivoryon found in the data. Varoglutamstat, a QPCT/L inhibitor, showed statistically significant improvements in kidney function (eGFR) in both the VIVIAD and VIVA-MIND Alzheimer’s trials. In diabetic patients, eGFR—a key marker of kidney health—improved by 8.2 mL/min/1.73m²/year compared to placebo. That’s a massive number, suggesting the drug could slow or even reverse kidney damage in DKD, a condition affecting millions globally.

The company is now planning a Phase 2b trial in DKD, enrolling 90 patients. If this trial hits its primary endpoint (changes in eGFR), it could fast-track varoglutamstat into larger studies. Preclinical data also hints at synergy when combining varoglutamstat with SGLT2 inhibitors like dapagliflozin—a blockbuster class of diabetes drugs that also protect kidneys. This combo could position Vivoryon’s therapy as a next-gen treatment in a multibillion-dollar market.

The Pipeline: Betting on Next-Gen Compounds

Vivoryon isn’t resting on varoglutamstat alone. Its next-gen compound, VY2149, boasts superior preclinical activity, including better effects on fibrosis markers. If this molecule lives up to expectations, it could outperform varoglutamstat and solidify Vivoryon’s position in kidney disease. Meanwhile, the company has strengthened its patent portfolio to 22 families, including a newly allowed U.S. patent for varoglutamstat’s composition of matter—a critical step to extend exclusivity.

The Risks: Running Out of Time and Cash

Here’s the rub: Vivoryon’s future hinges on two things—securing more funding and nailing that Phase 2b trial. The company’s “going concern” status is conditional on raising additional capital or forming partnerships. If the DKD trial fails or funding dries up, Vivoryon could be in freefall.

Investors should also note that the SEPA agreement isn’t a guarantee. Yorkville Advisors can invest up to €15 million, but they’re under no obligation to do so. And while the cash runway to early 2026 sounds long, it assumes no unexpected costs—a big ask for a biotech.

Conclusion: A High-Reward, High-Risk Play

Vivoryon is a classic “all-in” bet. The data on varoglutamstat in DKD is compelling—8.2 mL/min/1.73m²/year improvement in eGFR is nothing short of groundbreaking. If the Phase 2b trial succeeds, Vivoryon’s stock could soar. But the path is littered with obstacles: cash constraints, reliance on external funding, and the ever-present risk of clinical trial failure.

For investors with a high risk tolerance and a long time horizon, Vivoryon could be a diamond in the rough. But don’t blink—this is a race against the clock. The stock’s current valuation (trading around €0.30 as of April 2025) reflects its precarious position, but a positive DKD trial result could trigger a 10x move.

In short: Vivoryon is either a future leader in kidney disease therapies or a cautionary tale. The data will decide—but make no mistake, the stakes here are enormous.