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Vivoryon Therapeutics N.V. Reports Q3 2026 Financial Results and Provides Business Update

Continued operations beyond the cash runway depend on additional funding, as Vivoryon also evaluates a company or asset sale.

(Moderate)

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Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.

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Vivoryon Therapeutics (VVY) reported a narrower nine-month net loss while continuing negotiations to fund varoglutamstat development in kidney disease. Net loss was EUR 4.8 million, versus EUR 7.6 million a year earlier, with zero revenue. Research and development expenses fell to EUR 2.3 million and administrative expenses to EUR 2.7 million. Cash was EUR 1.7 million at September 30, 2026, versus EUR 5.6 million at year-end 2025.

The company expects cost savings to extend its runway into the second half of December 2026; continued operations and planned Phase 2b testing require funding. An agreement with Simcere returns Greater China rights to varoglutamstat and PBD-C06 without an upfront cash payment, with potential future varoglutamstat regulatory milestone payments. Vivoryon is also assessing a company or asset sale. A computational analysis linked preclinical treatment responses with human kidney disease processes.

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1 major · 6 points

Hollow bars mark forward-looking points. How the balance works

Positive

  • Moderate pointNine-month net loss narrowed to EUR 4.8 million from EUR 7.6 million in 2025.
  • Moderate point. Forward-looking: it has not happened yet and may not happen.Additional cost savings extend expected cash runway into the second half of December 2026.
  • Moderate pointSimcere agreement returns Greater China rights to varoglutamstat and PBD-C06, with no cash payment upon termination.
  • Moderate pointVIVIAD and VIVA-MIND showed statistically significant kidney-function improvement versus placebo in two independent randomized, double-blind studies.
  • Moderate point. Forward-looking: it has not happened yet and may not happen.Planned Phase 2b study aims to confirm results in stage 3b/4 diabetic kidney disease.
3 minor points
  • Minor pointResearch and development expenses fell to EUR 2.3 million from EUR 3.7 million for the nine-month period.
  • Minor pointGeneral and administrative expenses fell to EUR 2.7 million from EUR 4.0 million for the nine-month period.
  • Minor pointLucera's computational analysis linked preclinical treatment responses to human kidney disease processes and identified mechanisms for experimental validation.

Negative

  • Major pointContinued operations beyond current guidance and going-concern status depend on additional funding.
  • Moderate pointCash fell to EUR 1.7 million at September 30, 2026, from EUR 5.6 million at December 31, 2025.
  • Moderate point. Forward-looking: it has not happened yet and may not happen.Phase 2b initiation and all future studies remain subject to additional funding and/or partnership.
  • Moderate point. Forward-looking: it has not happened yet and may not happen.Vivoryon expects continued operating losses for the foreseeable future.
  • Minor pointSimcere is eligible for future payments upon specified Greater China regulatory milestones for varoglutamstat.
  • Minor pointNine-month revenue remained zero, unchanged from the same period in 2025.

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Vivoryon Therapeutics N.V. Reports Q3 2026 Financial Results
and Provides Business Update

  • Ongoing negotiations with different parties towards securing a partnership or financing for the development of varoglutamstat in kidney disease
  • Agreement with partner Simcere Pharmaceutical Group Ltd. to regain development and commercial rights for lead asset varoglutamstat in Greater China, consolidating global rights and supporting Vivoryon’s strategic focus on kidney disease
  • New analysis performed by Lucera GmbH, a biomedical intelligence company, links preclinical treatment responses to human disease processes, further strengthening the dataset supporting varoglutamstat’s MoA in kidney disease
  • Updated financial guidance: additional cost-saving measures extend expected cash runway into the second half of December 2026

Halle (Saale) / Munich, Germany, November 5, 2026 - Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company developing small molecule medicines for inflammatory and fibrotic disorders, with a primary focus on kidney diseases, today announced financial results for the nine-month period ended September 30, 2026, and provided a corporate update.

“We remain engaged in negotiations with different parties regarding a partnership or financing for the development of varoglutamstat in kidney disease,” said Frank Weber, MD, CEO of Vivoryon. “The agreement with Simcere consolidates worldwide rights to varoglutamstat, simplifying the rights structure for potential partners, while additional cost-saving measures extend our operating runway into the second half of December 2026. Our priority is to secure funding for the planned Phase 2b study. In parallel, we are evaluating alternative strategic and financing options, taking into account the available cash runway and the potential of each option to preserve and realize shareholder value.”

Q3 2026 and Post-Period Updates

Strategic Priorities
Vivoryon's key strategic priority remains securing the funding necessary to advance varoglutamstat into a Phase 2b clinical study in patients with advanced diabetic kidney disease (DKD), with the aim of confirming the compelling data observed in the VIVIAD and VIVA-MIND studies. The Company continues negotiations with different parties towards securing a partnership or financing for the development of varoglutamstat in kidney disease. In parallel, Vivoryon is assessing alternative strategic and financing options, including a potential sale of the Company or a sale of assets.

Corporate Updates

  • In September 2026, Vivoryon held its 2026 Annual General Meeting (AGM) in Amsterdam, the Netherlands. The shareholders approved all items on the agenda of the meeting.
  • Vivoryon has recently signed an agreement with partner Simcere Pharmaceutical Group Ltd. to regain development and commercial rights for lead asset varoglutamstat in Greater China, consolidating global rights and supporting the Company’s strategic focus on kidney disease. The Termination Agreement covers the existing regional licensing partnership for the development and commercialization of medicines targeting the neurotoxic amyloid species N3pE (pGlu-Abeta) to treat Alzheimer's disease (AD) in Greater China, resulting in the return of all development and commercialization rights for varoglutamstat as well as Vivoryon's pre-clinical stage monoclonal N3pE-antibody PBD-C06 in this territory to Vivoryon. Under the terms of the Termination Agreement, no cash payment is due by Vivoryon upon termination. Simcere will be eligible to receive certain payments upon the achievement of specified future regulatory milestones in Greater China for varoglutamstat.

Varoglutamstat Program Overview and Updates

Vivoryon’s varoglutamstat Phase 2 program has shown highly consistent, statistically significant and clinically meaningful improvement of kidney function (eGFR) versus placebo in two independent randomized double-blind placebo-controlled studies, VIVIAD and VIVA-MIND. The Company is planning to confirm these results in a dedicated Phase 2b clinical study in patients with DKD stage 3b/4. Initiation of the Phase 2b and all future studies is subject to additional funding and/or partnership, which Vivoryon continues to actively explore.

Vivoryon has continued to actively expand and strengthen pre-clinical and clinical data sets for varoglutamstat, as well as present updates on the growing body of evidence validating glutaminyl cyclases (QPCT/L) as promising targets in DKD at the World Congress of Nephrology, Japan.

A new computational analysis by Lucera GmbH, a biomedical intelligence company, provides further mechanistic support for the development of varoglutamstat in kidney disease. By integrating preclinical gene-expression data for varoglutamstat and one of Vivoryon’s second-generation QPCT/L inhibitors with human kidney disease datasets, the analysis identified molecular networks connecting treatment responses with inflammatory and fibrotic processes implicated in kidney disease progression. These findings extend the mechanistic rationale beyond individual inflammatory pathways and support investigation of a broader role for QPCT/L inhibition in kidney disease. The analysis also prioritized potential mechanisms for additional experimental validation.

Financial Results for the Nine Months Ended September 30, 2026

Revenues were zero in the nine months ended September 30, 2026, as well as in the nine months ended September 30, 2025.

Research and development expenses decreased by EUR 1.4 million to EUR 2.3 million in the nine months ended September 30, 2026, compared to EUR 3.7 million in the nine months ended September 30, 2025. This reduction was largely attributable to a decrease in clinical development and analysis costs of EUR 1.0 million related to kidney research.

General and administrative expenses were EUR 2.7 million in the nine months ended September 30, 2026, compared to EUR 4.0 million in the nine months ended September 30, 2025. The decrease was largely attributable to lower non-cash-effective share-based personnel costs of EUR 0.6 million and the implementation of cost-saving measures.

Net loss for the nine months ended September 30, 2026, was EUR 4.8 million, compared to EUR 7.6 million for the nine months ended September 30, 2025.

The Company held EUR 1.7 million in cash and cash equivalents as of September 30, 2026, compared to EUR 5.6 million as of December 31, 2025.

Outlook & Financial Guidance

The Company expects, based on its most recent financial and business plan, that its existing cash and cash equivalents will now be sufficient to fund its operating plans into the second half of December 2026, subject to the occurrence of unforeseen circumstances and without taking into account any funds from the SEPA as well as other potential additional financing transactions, if any.

This cash runway guidance reflects an overall reduction in cash utilization while prudently investing in preparing to execute on the Company’s kidney disease strategy. The initiation of the Phase 2b DKD study and all future studies is subject to further additional funding and/or partnership, which the Company continues to actively explore.

The viability of the Company’s business beyond its current guidance 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.

The Company expects to have continued operating losses for the foreseeable future and will require additional funding to continue operations beyond the current financial guidance. The Company has concluded that the ability to continue as a going concern, depends on the ability to generate additional funding. For further information please refer to the Company’s Annual Report 2025 published on April 23, 2026.

All ongoing negotiations and potential partnerships remain subject to the customary risks and uncertainties associated with such processes, and there can be no assurance that any transaction or investment will materialize.

###

About Vivoryon Therapeutics N.V.
Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines for the treatment of inflammatory and fibrotic disorders of the kidney. Driven by its passion for ground-breaking science and innovation, the Company strives to improve patient outcomes by changing the course of severe diseases through modulating the activity and stability of pathologically relevant proteins. Vivoryon’s most advanced program, varoglutamstat, a proprietary, first-in-class orally available QPCT/L inhibitor, is being evaluated to treat diabetic kidney disease. www.vivoryon.com 

Vivoryon Forward Looking Statements
This press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of Vivoryon Therapeutics N.V. (the “Company”), estimates and projections with respect to the market for the Company’s products and forecasts and statements as to when the Company’s products may be available. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management’s current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. The Company’s results of operations, cash needs, financial condition, liquidity, prospects, future transactions, strategies or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company’s future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law.

For more information, please contact:

Vivoryon Therapeutics N.V.
Dr. Manuela Bader, Director IR & Communication
Email: IR@vivoryon.com

LifeSci Advisors
Sandya von der Weid
Tel: +41 78 680 05 38
Email: svonderweid@lifesciadvisors.com

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FAQ

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How long does Vivoryon Therapeutics expect its cash to last?

Vivoryon expects existing cash and cash equivalents to fund operating plans into the second half of December 2026. The forecast excludes funds from the SEPA and any other potential additional financing transactions, and is subject to unforeseen circumstances.

What rights is Vivoryon Therapeutics regaining from Simcere?

Vivoryon is regaining Greater China development and commercialization rights for varoglutamstat and the preclinical antibody PBD-C06. No cash payment is due upon termination of the regional licensing partnership. Simcere remains eligible for payments upon specified future regulatory milestones in Greater China for varoglutamstat.

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