Vivoryon Therapeutics N.V. Reports H1 2026 Financial Results and Provides Business Update
Vivoryon Therapeutics N.V. Reports H1 2026 Financial Results and Provides Business Update
- Strategic partnering remains a key priority, with multiple strategic discussions progressing, including advanced term sheet negotiations for a potential licensing agreement
- Gained further insight into varoglutamstat’s unique mechanism of action and therapeutic potential in kidney disease
- Financial guidance maintained: Vivoryon expects cash and cash equivalents to be sufficient for funding operations into Q4 2026
- Management to host a conference call today at 3:00 pm CEST (9:00 am EDT)
Halle (Saale) / Munich, Germany, August 6, 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 six-month period ended June 30, 2026, and provided a corporate update. The half year report is available on the Company’s website https://www.vivoryon.com/financial-information/.
“Throughout the first half of this year we continued to see increased external interest in varoglutamstat in kidney disease. We have made meaningful progress in our partnering efforts and are currently in advanced term sheet negotiations for a potential licensing agreement. Separately, a specialist kidney-focused investor is conducting an independent assessment of selected aspects of the varoglutamstat program in connection with its evaluation of a potential investment,” said Frank Weber, MD, CEO of Vivoryon. “We are highly encouraged by the level of external engagement and remain focused on securing the funding and partnership required to advance the Phase 2b program for varoglutamstat, and look forward to providing you with an update in due course.”
H1 2026 and Post-Period Updates
Strategic Priorities Vivoryon's key strategic priority is to secure the funding necessary to advance varoglutamstat into a Phase 2b clinical study in patients with advanced diabetic kidney disease (DKD) stage 3b/4 in order to confirm the compelling data observed in the VIVIAD and VIVA-MIND studies. Throughout the reporting period and in recent months, multiple strategic discussions have been progressing. The Company is advancing negotiations with different parties towards securing beneficial partnerships for varoglutamstat in kidney disease and is currently in advanced term sheet negotiations for a potential licensing agreement. Separately, a specialist kidney-focused investor is conducting an independent assessment of selected aspects of the varoglutamstat program in connection with its evaluation of a potential investment. Vivoryon also continues to engage with additional strategic parties to maximize the full potential of the QPCT/L platform. Note that all ongoing negotiations and potential investments are subject to the typical risks and uncertainties associated with such processes and there can be no guarantee that any transaction or investment will materialize.
Varoglutamstat Program The strong clinical and preclinical data and analyses generated to date continue to support advancement of varoglutamstat in advanced diabetic kidney disease (DKD). Vivoryon's Phase 2 clinical program with varoglutamstat has consistently demonstrated statistically significant and clinically meaningful improvements in kidney function (eGFR) versus placebo across two independent randomized, double-blind, placebo-controlled studies in elderly participants, VIVIAD and VIVA-MIND. Based on these findings, the Company is preparing to advance varoglutamstat into a dedicated Phase 2b clinical trial in patients with stage 3b/4 diabetic kidney disease (DKD), subject to securing additional funding and/or a strategic partnership.
Further elucidated varoglutamstat’s MOA
- The Company continues to strengthen the scientific understanding of varoglutamstat‘s mechanism of action through an expanding preclinical data package. New preliminary findings from a CKD animal model show, on the molecular level, a significant beneficial effect of varoglutamstat on the endothelial cells in the kidney. These cells are a crucially important part of the kidneys’ filtration barrier, whose integrity is a key factor in maintaining kidney function. The new pathway analysis data support an improvement of endothelial cell function via activation of HIF pathways and upregulation of VEGF in response to varoglutamstat, which may lead to a reversal of capillary rarefaction, the prevention of endothelial cell death as well as vascular stabilization. Together with additional pre-clinical data on varoglutamstat’s molecular mechanisms, these findings further reinforce the therapeutic rationale for targeting QPCT/L in kidney disease.
- Vivoryon published a pre-recorded webcast in April 2026 which contextualizes pre-clinical data relating to the biological mechanisms of varoglutamstat’s kidney benefits observed in VIVIAD and VIVA-MIND. This included evidence of the role of QPCT and QPCTL in inflammation, fibrosis and collagen maturation, as well as data demonstrating the positive effects of varoglutamstat on podocytes, the specialized cells essential for maintaining kidney filtration function. The webcast is available here: https://www.vivoryon.com/science-insights-understanding-varoglutamstat/
Presented new analyses at key international medical meeting
- Vivoryon presented new analyses further validating QPCT/L as promising therapeutic targets in DKD at the World Congress of Nephrology (WCN) 2026 in Yokohama, Japan. The data reinforced previous findings that varoglutamstat's effect on eGFR was more pronounced in elderly participants with diabetes than in those without diabetes. Among participants with diabetes and lower baseline kidney function (mean eGFR of 60 mL/min/1.73m²), treatment effects were comparable to or greater than those observed in the overall diabetic population. Also presented at WCN were findings from a DKD mouse model showing significant improvements in inflammation, glomerulosclerosis and kidney function with varoglutamstat.
Proposed clinical development plan in DKD The Company is planning to conduct a randomized, placebo-controlled Phase 2b study in patients with advanced DKD stage 3b/4 to confirm the compelling effects of varoglutamstat on kidney function observed in the VIVIAD and VIVA-MIND Phase 2 studies in elderly patients. Initiation of the Phase 2b and all future studies is subject to additional funding and/or partnership, which Vivoryon continues to actively explore.
Corporate Update The Company plans to host its 2026 Annual General Meeting on September 29, 2026 in Amsterdam, The Netherlands. The convocation note and all related materials will be made available on the Company’s website in due time.
Financial Results for the First Half of 2026
Revenues were zero in the six months ended June 30, 2026, as well as in the six months ended June 30, 2025.
Research and development expenses decreased by EUR 1.1 million to EUR 1.7 million in the six months ended June 30, 2026, compared to EUR 2.8 million in the six months ended June 30, 2025. This reduction was largely attributable to a decrease in clinical development costs of EUR 0.6 million related to kidney research and a reduction of associated patent and consulting fees of EUR 0.2 million.
General and administrative expenses were EUR 1.7 million in the six months ended June 30, 2026, compared to EUR 2.8 million in the six months ended June 30, 2025. The decrease of EUR 1.1 million was largely attributable to less non-cash-effective share-based personnel costs of EUR 0.4 million and a decrease in legal costs of EUR 0.4 million.
Net loss for the six months ended June 30, 2026, was EUR 3.4 million, compared to EUR 5.5 million for the six months ended June 30, 2025.
The Company held EUR 2.4 million in cash and cash equivalents as of June 30, 2026, compared to EUR 5.6 million as of December 31, 2025. Outlook & financial guidance As published on April 23, 2026, the issuance date of its annual Financial Statements 2025, the Company expects, based on its most recent financial and business plan, that its existing cash and cash equivalents will be sufficient to fund its operating plans into the fourth quarter of 2026, subject to the occurrence of unforeseen circumstances and without taking into account any potential financing through its standby equity purchase agreement (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. Funding operations beyond its current guidance as well as initiation of the planned Phase 2b DKD study and all future studies are 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 the need to raise additional capital to finance its future operations. The Company has concluded that the ability to continue as a going concern in the financial year 2026, as stated in the Company’s Annual Report 2025 published on April 23, 2026, depends on the ability to generate additional funding. Please refer to the Company’s Annual Report 2025 for further information.
Conference call and webcast
Vivoryon will host a conference call and webcast today, August 6, 2026, at 3:00 pm CEST (9:00 am EDT). A Q&A session will follow the presentation of the half year results.
A live webcast and slides will be made available at: https://www.vivoryon.com/news-and-events/presentations-webcasts/
To join the conference call via phone, participants may pre-register and will receive dedicated dial-in details to easily and quickly access the call via the following website: https://register-conf.media-server.com/register/BI50ce93e709a44bffb7f6c948d6740864
It is suggested participants dial into the conference call 15 minutes prior to the scheduled start time to avoid any delays in attendance.
Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: https://www.vivoryon.com/news-and-events/presentations-webcasts/
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Vivoryon Therapeutics N.V. Financial Statements Unaudited Statement of Operations and Comprehensive Loss for the Six Months Ended June 30, 2026 and 2025
| For the six months ended June 30, | ||
| in kEUR, except for share data | 2026 (unaudited) | 2025 (unaudited) |
| Research and development expenses | (1,659) | (2,768) |
| General and administrative expenses | (1,732) | (2,755) |
| Operating loss | (3,391) | (5,523) |
| Finance income | 27 | 74 |
| Finance expenses | (24) | (24) |
| Finance result | 3 | 50 |
| Result before income taxes | (3,388) | (5,473) |
| Income taxes | — | — |
| Net loss for the period | (3,388) | (5,473) |
| Items not to be reclassified subsequently to profit or loss | ||
| Remeasurement of the net defined benefit pension liability | (5) | 26 |
| Total other comprehensive profit / (loss) | (5) | 26 |
| Comprehensive loss | (3,393) | (5,447) |
| Loss per share in EUR (basic and diluted) | (0.11) | (0.21) |
The accompanying notes are an integral part of these condensed interim financial statements.
Vivoryon Therapeutics N.V. Unaudited Condensed Statements of Financial Position as of June 30, 2026 and December 31, 2025 (audited)
| in kEUR | June 30, 2026 (unaudited) | December 31,2025 (audited) |
| ASSETS | ||
| Non-current assets | ||
| Property, plant and equipment | 6 | 13 |
| Intangible assets | 765 | 797 |
| Right-of-use assets | 76 | 108 |
| Other non-current assets | 182 | 173 |
| Total non-current assets | 1,029 | 1,091 |
| Current assets | ||
| Financial assets | 98 | 33 |
| Other current assets and prepayments | 594 | 775 |
| Cash and cash equivalents | 2,446 | 5,619 |
| Total current assets | 3,138 | 6,427 |
| TOTAL ASSETS | 4,167 | 7,518 |
| Equity | ||
| Share capital | 296 | 296 |
| Share premium | 166,218 | 166,218 |
| Other capital reserves | 16,901 | 16,670 |
| Accumulated other comprehensive loss | (242) | (237) |
| Accumulated deficit | (181,608) | (178,220) |
| Total equity | 1,565 | 4,727 |
| Non-current liabilities | ||
| Pension liability | 1,211 | 1,232 |
| Provisions long-term | 692 | 678 |
| Lease liability | 11 | 44 |
| Total non-current liabilities | 1,914 | 1,954 |
| Current liabilities | ||
| Trade payables | 388 | 458 |
| Lease liabilities | 65 | 64 |
| Other liabilities | 235 | 315 |
| Total current liabilities | 688 | 837 |
| Total Liabilities | 2,602 | 2,791 |
| TOTAL EQUITY AND LIABILITIES | 4,167 | 7,518 |
The accompanying notes are an integral part of these condensed interim financial statements.
Vivoryon Therapeutics N.V. Unaudited Condensed Statements of Changes in Shareholders’ Equity for the six months ended June 30, 2026 and 2025
| in kEUR | Share capital | Share premium | Other capital reserves | Accumulated other comprehensive loss | Accumulated deficit | Total equity |
| January 1, 2026 | 296 | 166,218 | 16,670 | (237) | (178,220) | 4,727 |
| Net loss for the period | — | — | — | — | (3,388) | (3,388) |
| Remeasurement of the net defined benefit pension liability | — | — | — | (5) | — | (5) |
| Comprehensive loss | — | — | — | (5) | (3,388) | (3,393) |
| Share-based payments | — | — | 231 | — | — | 231 |
| June 30, 2026 | 296 | 166,218 | 16,901 | (242) | (181,608) | 1,565 |
| January 1, 2025 | 261 | 161,477 | 15,777 | (268) | (169,367) | 7,880 |
| Net loss for the period | — | — | — | — | (5,473) | (5,473) |
| Remeasurement of the net defined benefit pension liability | — | — | — | 26 | — | 26 |
| Comprehensive loss | — | — | — | 26 | (5,473) | (5,477) |
| Proceeds from the issuance of common shares | 1 | — | — | — | — | 1 |
| Share-based payments | — | — | 747 | — | — | 747 |
| June 30, 2025 | 262 | 161,477 | 16,524 | (242) | (174,840) | 3,181 |
The accompanying notes are an integral part of these condensed interim financial statements.
Vivoryon Therapeutics N.V. Unaudited Condensed Statements of Cash Flows for the six months ended June 30, 2026 and 2025
| For the six months ended June 30, | ||
| in kEUR | 2026 (unaudited) | 2025 (unaudited) |
| Operating activities | ||
| Net loss for the period | (3,388) | (5,473) |
| Adjustments for: | ||
| Finance result | (3) | (50) |
| Depreciation and amortization | 67 | 73 |
| Share based payments | 231 | 747 |
| Foreign currency gain (loss) from other items than cash | (1) | 3 |
| Other non-cash adjustments | — | 1 |
| Changing in: | ||
| Financial assets | (75) | — |
| Provisions long term | 14 | 0 |
| Other current and non-current assets and prepayments | 172 | 262 |
| Other long-term assets | — | (27) |
| Pension liabilities | (47) | (47) |
| Trade payables | (70) | 10 |
| Other liabilities | (79) | (96) |
| Interest received | 35 | 103 |
| Interest paid | (1) | (2) |
| Cash flows used in operating activities | (3,145) | (4,496) |
| Investing activities | ||
| (Purchase) / sale of plant and equipment | 4 | (4) |
| Cash flows used in investing activities | 4 | (4) |
| Financing activities | ||
| Payment of lease liabilities | (32) | (30) |
| Proceeds from the issuance of common shares | — | 2 |
| Cash flows provided by financing activities | (32) | (28) |
| Net change in cash and cash equivalents | (3,173) | (4,528) |
| Cash and cash equivalents at the beginning of period | 5,619 | 9,365 |
| Cash and cash equivalents at end of period | 2,446 | 4,837 |
The accompanying notes are an integral part of these condensed interim financial statements.
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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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