STOCK TITAN

Vivoryon Therapeutics N.V. Reports H1 2025 Financial Results and Business Updates

Rhea-AI Impact
(Moderate)
Rhea-AI Sentiment
(Neutral)
Tags

Vivoryon Therapeutics N.V. (VVY) reported H1 2025 financial results and significant progress in their kidney disease program. Key highlights include compelling kidney function data from two Phase 2 studies (VIVIAD and VIVA-MIND), showing varoglutamstat's ability to improve eGFR values. The company secured a new U.S. patent for varoglutamstat extending protection through 2044.

Financial results show a reduced net loss of EUR 5.5M compared to EUR 13.6M in H1 2024, with R&D expenses decreasing to EUR 2.8M from EUR 10.3M. Cash position stands at EUR 4.8M, expected to fund operations into January 2026. The company entered a EUR 15M Standby Equity Purchase Agreement with Yorkville Advisors and is actively seeking additional funding for planned Phase 2b DKD studies.

Pre-clinical data revealed synergistic effects when combining varoglutamstat with SGLT-2 inhibitors, showing promising results in inflammation, fibrosis, and kidney function markers.

Vivoryon Therapeutics N.V. (VVY) ha comunicato i risultati finanziari del primo semestre 2025 e i progressi rilevanti nel programma sulle malattie renali. Tra i punti salienti, i dati clinici sui reni provenienti da due studi di Fase 2 (VIVIAD e VIVA-MIND) mostrano come varoglutamstat migliori i valori di eGFR. L'azienda ha inoltre ottenuto un nuovo brevetto statunitense per varoglutamstat che estende la protezione fino al 2044.

I risultati finanziari evidenziano una perdita netta ridotta a 5,5 mln EUR rispetto a 13,6 mln EUR nel primo semestre 2024, con costi di R&S diminuiti a 2,8 mln EUR da 10,3 mln EUR. La posizione di cassa è di 4,8 mln EUR, stimata sufficiente per finanziare le operazioni fino a gennaio 2026. L'azienda ha firmato un accordo Standby Equity Purchase da 15 mln EUR con Yorkville Advisors e sta attivamente cercando ulteriori finanziamenti per gli studi di Fase 2b sulla DKD pianificati.

Dati preclinici mostrano effetti sinergici combinando varoglutamstat con inibitori SGLT-2, con risultati promettenti su infiammazione, fibrosi e marcatori della funzione renale.

Vivoryon Therapeutics N.V. (VVY) presentó los resultados financieros del primer semestre de 2025 y avances importantes en su programa sobre enfermedades renales. Entre los aspectos destacados, los datos renales de dos estudios de Fase 2 (VIVIAD y VIVA-MIND) muestran que varoglutamstat mejora los valores de eGFR. La compañía obtuvo una nueva patente en EE. UU. para varoglutamstat que extiende la protección hasta 2044.

Los resultados financieros muestran una pérdida neta reducida a 5,5 M EUR frente a 13,6 M EUR en el primer semestre de 2024, con gastos de I+D que disminuyeron a 2,8 M EUR desde 10,3 M EUR. La posición de caja es de 4,8 M EUR, que se espera financie las operaciones hasta enero de 2026. La empresa suscribió un Acuerdo de Compra de Acciones en Espera (Standby Equity Purchase Agreement) por 15 M EUR con Yorkville Advisors y busca activamente financiación adicional para los estudios de Fase 2b en DKD previstos.

Los datos preclínicos revelan efectos sinérgicos al combinar varoglutamstat con inhibidores SGLT-2, mostrando resultados prometedores en inflamación, fibrosis y marcadores de función renal.

Vivoryon Therapeutics N.V. (VVY)는 2025년 상반기 재무실적과 신장 질환 프로그램에서의 주요 진전을 발표했습니다. 주요 내용으로는 두 건의 2상 연구(VIVIAD 및 VIVA-MIND)에서 varoglutamstat가 eGFR 수치를 개선하는 유의미한 신장 기능 데이터를 제시한 점이 있습니다. 회사는 varoglutamstat에 대한 새로운 미국 특허를 획득해 보호 기간을 2044년까지 연장했습니다.

재무 결과는 순손실이 550만 유로로 축소되어 2024년 상반기의 1,360만 유로에서 개선되었고, 연구개발비는 1,030만 유로에서 280만 유로로 감소했습니다. 현금 보유액은 480만 유로로, 2026년 1월까지 운영 자금으로 충분할 것으로 예상됩니다. 회사는 Yorkville Advisors와 1,500만 유로 규모의 대기형 주식매입 계약(Standby Equity Purchase Agreement)을 체결했으며, 예정된 당뇨성 신장병(DKD) 2b상 연구를 위한 추가 자금 조달을 적극적으로 모색 중입니다.

전임상 데이터는 varoglutamstat과 SGLT-2 억제제를 병용할 때 염증, 섬유화 및 신장 기능 마커에서 유망한 상승 효과(시너지)를 보였음을 밝혔습니다.

Vivoryon Therapeutics N.V. (VVY) a publié ses résultats financiers du premier semestre 2025 et des progrès significatifs dans son programme sur les maladies rénales. Parmi les faits marquants, les données rénales issues de deux études de phase 2 (VIVIAD et VIVA‑MIND) montrent que le varoglutamstat améliore les valeurs d'eGFR. La société a obtenu un nouveau brevet américain pour le varoglutamstat prolongeant la protection jusqu'en 2044.

Les résultats financiers font état d'une perte nette réduite à 5,5 M EUR contre 13,6 M EUR au S1 2024, les dépenses R&D ayant diminué à 2,8 M EUR contre 10,3 M EUR. La trésorerie s'élève à 4,8 M EUR, suffisante selon les prévisions pour financer les opérations jusqu'en janvier 2026. La société a conclu un accord Standby Equity Purchase de 15 M EUR avec Yorkville Advisors et recherche activement des financements supplémentaires pour les études de phase 2b prévues en DKD.

Des données précliniques ont révélé des effets synergiques en combinant le varoglutamstat avec des inhibiteurs SGLT‑2, montrant des résultats prometteurs sur l'inflammation, la fibrose et les marqueurs de la fonction rénale.

Vivoryon Therapeutics N.V. (VVY) meldete die Finanzergebnisse für H1 2025 und bedeutende Fortschritte im Nierenerkrankungsprogramm. Zu den Highlights zählen aussagekräftige Nierenfunktionsdaten aus zwei Phase‑2‑Studien (VIVIAD und VIVA‑MIND), die zeigen, dass Varoglutamstat die eGFR-Werte verbessert. Das Unternehmen erhielt außerdem ein neues US‑Patent für Varoglutamstat, das den Schutz bis 2044 verlängert.

Die Finanzzahlen weisen einen verringerten Nettoverlust von 5,5 Mio. EUR gegenüber 13,6 Mio. EUR in H1 2024 aus, wobei die F&E‑Aufwendungen auf 2,8 Mio. EUR von 10,3 Mio. EUR zurückgingen. Die Liquiditätsposition beträgt 4,8 Mio. EUR und soll die Geschäftstätigkeit bis Januar 2026 finanzieren. Das Unternehmen schloss eine 15 Mio. EUR Standby‑Equity‑Purchase‑Vereinbarung mit Yorkville Advisors ab und sucht aktiv weitere Mittel für geplante Phase‑2b‑Studien zur DKD.

Präklinische Daten zeigten synergistische Effekte bei der Kombination von Varoglutamstat mit SGLT‑2‑Inhibitoren und vielversprechende Ergebnisse bei Entzündung, Fibrose und Nierenfunktionsmarkern.

Positive
  • New U.S. patent granted for varoglutamstat with protection through 2044
  • Significant improvement in kidney function (eGFR) demonstrated in meta-analysis of two Phase 2 studies
  • Net loss reduced by 59.7% to EUR 5.5M from EUR 13.6M year-over-year
  • Secured EUR 15M Standby Equity Purchase Agreement with Yorkville Advisors
  • Pre-clinical data showed strong synergistic effects with SGLT-2 inhibitors
Negative
  • Cash position decreased to EUR 4.8M from EUR 9.4M in December 2024
  • Current cash runway only extends into January 2026
  • Phase 2b DKD study initiation dependent on securing additional funding
  • Material uncertainty about ability to continue as going concern in 2026
  • Zero revenues reported for H1 2025

Insights

Vivoryon shows promising kidney function data for varoglutamstat with patent protection through 2044, but faces significant financial constraints requiring additional funding.

Vivoryon's H1 2025 results reveal significant progress for their lead candidate varoglutamstat in kidney disease, with two key developments standing out. First, their meta-analysis of the VIVIAD and VIVA-MIND studies demonstrated statistically significant improvement in kidney function (measured by eGFR) starting at week 24 and continuing through week 96, with particularly strong effects in diabetic patients. This provides critical clinical validation for their approach targeting QPCT/L inhibition in kidney disease.

The second major achievement is securing a composition of matter patent for varoglutamstat's active polymorph, granted after accelerated USPTO review with exclusivity through 2044 and potential extension to 2049. This substantially strengthens their commercial position and partnering prospects.

Pre-clinical data showing synergistic effects when combining varoglutamstat with SGLT-2 inhibitors (standard-of-care kidney medications) is particularly compelling, as it suggests their compound could complement existing therapies by addressing underlying inflammatory and fibrotic pathways. Their mechanistic studies confirming dose-dependent reduction of inflammatory biomarker pE-CCL2 correlating with improved kidney function provides strong scientific rationale for their approach.

However, their financial position remains challenging. With only €4.8 million in cash as of June 30 (down from €9.4 million at year-end 2024), their runway extends only into January 2026. While R&D expenses decreased significantly to €2.8 million (from €10.3 million) due to completed clinical trials, they explicitly state that initiating their planned Phase 2b diabetic kidney disease study depends on securing additional funding and/or partnerships. Their €15 million Standby Equity Purchase Agreement with Yorkville remains unused, indicating possible reluctance to dilute at current valuations.

The disclosed going concern uncertainty for 2026 presents a significant risk, making successful fundraising or partnership deals crucial for advancing their promising kidney disease program despite the strong clinical and scientific progress.

Vivoryon Therapeutics N.V. Reports H1 2025 Financial Results and Business Updates

  • Compelling kidney function data and meta-analysis from two Phase 2 studies, VIVIAD and VIVA-MIND, presented in oral presentation at ERA 2025
  • Expanded IP portfolio including novel composition of matter patent for varoglutamstat granted after accelerated review in the U.S.; patent term to provide exclusivity through 2044 with subsequent opportunity for patent term extension
  • Pre-clinical data showing strong additive and synergistic effect of combination treatment with varoglutamstat and an SGLT-2 inhibitor; new VIVIAD analyses and pre-clinical data continue to support varoglutamstat’s mechanism of action and potential in kidney disease
  • Preparations ongoing for Phase 2b of varoglutamstat in diabetic kidney disease (DKD)
  • Management to host conference call today at 3:00 pm CEST (9:00 am EDT)

Halle (Saale) / Munich, Germany, September 4, 2025 - 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, 2025, and provided a corporate update. The report is available on the Company’s website https://www.vivoryon.com/financial-information/.

“In the first half of 2025, we have continued making substantial progress in advancing varoglutamstat in kidney disease, including significantly extending protection of our key asset varoglutamstat with a new composition of matter patent in the U.S.,” said Frank Weber, MD, CEO of Vivoryon. “We were especially pleased to share our outstanding clinical study results with the medical community at ERA in June, further solidifying our view of varoglutamstat potentially becoming a novel therapeutic option for patients affected by kidney disease. Our data underscore varoglutamstat’s unique ability to stabilize and even improve kidney function, as measured by eGFR values. Moreover, we are excited to have compiled evidence of a potential synergistic effect of varoglutamstat in combination with SGLT-2 inhibitors for which we have generated very promising pre-clinical data. We are continuing to elucidate varoglutamstat’s mechanism of action in kidney disease. As more and more datapoints complete the picture, we strongly believe that varoglutamstat can effectively address the significant unmet need for new therapies that tackle the underlying inflammatory and fibrotic changes which are key drivers of disease progression in patients with CKD and DKD.”

H1 2025 and Post-Period Updates

Varoglutamstat Clinical Program
Meta-analysis of VIVIAD and VIVA-MIND study data

  • On January 14, 2025, the Company disclosed a meta-analysis of VIVIAD and VIVA-MIND data which confirmed that treatment with varoglutamstat at 600 mg twice daily significantly improved eGFR kidney function in the overall study population. Statistically significant differences between varoglutamstat and placebo were first observed at week 24 and were sustained until week 96.
  • The meta-analysis also confirmed a substantially larger effect size in study participants with diabetes compared to those without diabetes.
  • Data were presented at the 62nd ERA Congress of the European Renal Association in Vienna, Austria, June 6, 2025, showing consistent improvement of kidney function in both studies independently, replicated in the meta-analysis and pooled analysis, thus providing consistent evidence for the findings.

Synergistic effect of combination treatment with varoglutamstat and SGLT-2 inhibitors in pre-clinical animal model

  • On April 29, 2025, Vivoryon disclosed pre-clinical data from a series of experiments in a chronic kidney disease animal model, analyzing different treatment regimens of varoglutamstat in combination with standard of care for kidney disease, the SGLT-2 inhibitor dapagliflozin.
  • Data analysis revealed a synergistic in vivo effect for the combination treatment of dapagliflozin and varoglutamstat over a broad panel of markers, nearly normalizing pathology vs. control across the three key areas of inflammation, fibrosis and kidney function.
  • Substantially de-risking the Company’s DKD/CKD clinical development program, the strong synergistic effects observed on multiple outcome parameters suggest that QPCT/L inhibitors could be an ideal combination partner for patients treated with SGLT-2 inhibitors.

New VIVIAD analyses and pre-clinical data continue to support varoglutamstat’s mechanism of action and potential in kidney disease
Vivoryon has recently completed a series of supporting clinical data analyses and pre-clinical experiments which provide further evidence for varoglutamstat’s potential to beneficially impact kidney function based on its proposed mechanism of action.

  • Vivoryon has investigated the effects of varoglutamstat on inflammation, fibrosis and kidney function in an established advanced mouse model of DKD with type 2 diabetes and hypertension (ReninAAV UNx db/db). QPCT/L inhibition with varoglutamstat led to a statistically significant reduction in inflammation (CD11c), fibrosis (glomerulosclerosis) and plasma creatinine, supporting an improvement in kidney function. These data corroborate the effect of varoglutamstat on key kidney disease biomarkers previously reported in the ADI/CKD model and add to the overall body of evidence supporting varoglutamstat’s potential in kidney disease including DKD.
  • Vivoryon has established a novel, highly specific liquid chromatography-mass spectrometry (LC/MS)-based assay for analysis of biomarker samples in humans. This assay eliminates the need for anti-pE-specific antibodies that are often difficult to generate, thus posing technical limitations. An analysis of the inflammatory biomarker pE-CCL2 of VIVIAD study samples with this specific assay showed a statistically significant, dose-dependent reduction of pE-CCL2 in study participants treated with varoglutamstat versus placebo, confirming the previous analyses.
  • Results from Vivoryon’s VIVIAD Phase 2b study previously showed that reduction of pE-CCL2 was associated with an improvement of kidney function as measured by eGFR in study participants with and without diabetes at a dose group level. A novel analysis of VIVIAD evaluating the correlation pE-CCL2 levels and eGFR slope on an individual participant level revealed a statistically significant correlation between the change from baseline in pE-CCL2 serum levels at week 48 and the eGFR slope over time. Specifically, a decrease in pE-CCL2 was significantly correlated with a positive (improved) eGFR slope.

Proposed clinical development plan in DKD

Vivoryon’s key strategic priority for 2025 is to advance varoglutamstat in kidney disease and confirm the previously reported compelling data from two independent Phase 2 studies, VIVIAD and VIVA-MIND, by conducting a Phase 2b clinical study in patients with advanced diabetic kidney disease (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.

Expanding intellectual property portfolio in kidney disease treatment

Vivoryon announced on May 27, 2025, that the United States Patent and Trademark Office (USPTO) has granted an additional patent covering the active polymorph of varoglutamstat. The new U.S. patent (US 12,312,335) was granted after an accelerated examination process and has a scheduled runtime through 2044 with subsequent opportunity for patent term extension of up to five years to 2049 under the Hatch-Waxman Act. Additional patents for medical use and dosing regimens are under examination for varoglutamstat and related structures in kidney disease as monotherapy and in combination with SGLT-2 inhibitors.

Pipeline Updates: Early-stage Pipeline

The Company has enlarged its portfolio by nominating a novel, next generation QPCT/L inhibitor showing compelling pharmacological activity. This candidate, VY2149, is a potential fast follower in DKD or could also be explored for other inflammatory and fibrotic diseases including orphan diseases and chronic kidney disease (CKD). VY2149 is currently in pre-clinical stage and further development is subject to additional funding and/or partnership, which Vivoryon continues to actively explore.

Corporate Development Updates

  • In April 2025, Vivoryon entered into a Standby Equity Purchase Agreement (SEPA) with

Yorkville Advisors Global, LP, allowing for the purchase of up to EUR 15 million in ordinary shares over the next 36 months. Under the terms of this agreement, Yorkville has committed to acquiring these shares, providing Vivoryon with the right, but not the obligation, to sell them in individual tranches while excluding existing shareholders’ pre-emptive rights. This agreement is expected to enhance Vivoryon’s financial flexibility as the company seeks optimal funding solutions for its planned Phase 2b study in diabetic kidney disease. As of today, Vivoryon has not initiated any tranches of the SEPA.

  • On May 1, 2025, Julia Neugebauer, PhD, assumed the newly created role of Chief Operating Officer (COO) of Vivoryon, heading investor relations and communications activities, spearheading market analysis, and overseeing various corporate functions.
  • Vivoryon held its 2025 Annual General Meeting (AGM) on June 24, 2025, in Amsterdam, the Netherlands. The shareholders approved all items on the agenda of the meeting. The full agenda and all relevant documents are available on the Company’s website (https://www.vivoryon.com/2025-annual-general-meeting/).
  • Vivoryon CFO Anne Doering will be taking a temporary partial leave of absence in the coming months to attend to a serious family health matter. During this period, Marcus Irsfeld will assume the role of acting CFO, ensuring continuity in financial operations and supporting the company’s strategic objectives.
    • Marcus is an experienced healthcare finance executive who has been working with Vivoryon as a strategic consultant since December 2024. He brings deep life sciences expertise, including five years as CFO of iOmx Therapeutics AG. He has also founded and co-founded several small and medium-sized enterprises, particularly in healthcare. He has led companies across Europe, the U.S., and China through all stages of growth, from founding and early-stage financing to exits and M&A. He holds a Masters degree in Business Administration (Diplom-Kaufmann) from the University of Münster.

 Financial Results for the First Half of 2025

Revenues were zero in the six months ended June 30, 2025, as well as in the six months ended June 30, 2024.

Research and development expenses decreased by EUR 7.5 million to EUR 2.8 million in the six months ended June 30, 2025, compared to EUR 10.3 million in the six months ended June 30, 2024. This reduction was largely attributable to a decrease in clinical development costs of EUR 5.6 million from the VIVIAD and VIVA-MIND studies and a reduction in production costs of EUR 1.5 million. R&D expenses in the reporting period mainly occurred for kidney related research.

General and administrative expenses were EUR 2.8 million in the six months ended June 30, 2025, compared to EUR 3.5 million in the six months ended June 30, 2024. The decrease of EUR 0.7 million was largely attributable to lower personnel costs of EUR 0.4 million and a decrease in legal and consulting cost of EUR 0.2 million.

Net loss for the six months ended June 30, 2025, was EUR 5.5 million, compared to EUR 13.6 million for the six months ended June 30, 2024.

The Company held EUR 4.8 million in cash and cash equivalents as of June 30, 2025, compared to EUR 9.4 million as of December 31, 2024.

Outlook & Financial Guidance
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 January 2026, subject to the occurrence of unforeseen circumstances and without taking into account any funds possibly raised under the SEPA as well as other potential additional financing transactions, if any. This guidance is in line with the cash runway update published on April 29, 2025, the issuance date of its annual Financing Statements 2024.
This cash runway guidance reflects an overall reduction in cash utilization including the conclusion of the VIVIAD and VIVA-MIND studies while prudently investing in preparing to execute on the Company’s kidney disease strategy. The initiation of the Phase 2b DKD study 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 continuing 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 2024 published on April 29, 2025, depends on the ability to generate additional funding. As such the Company has concluded that a material uncertainty exists that may cast significant doubt about its ability to continue as a going concern.
Please refer to the Company’s Annual Report 2024 for further information.

Conference Call and Webcast
Vivoryon will host a conference call and webcast today, September 4, 2025, at 3:00 pm CEST (9:00 am EDT). A Q&A session will follow the presentation of the first half 2025 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/BI5a3854fa349d497f8979340542813a0f

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/

 

###

 

Vivoryon Therapeutics N.V. Financial Statements
Unaudited Statement of Operations and Comprehensive Loss for the Six Months Ended June 30, 2025 and 2024

 For the six months
ended June 30,
in kEUR, except for share data2025
(unaudited)
2024
(unaudited)
   
Research and development expenses(2,768)(10,308)
General and administrative expenses(2,755)(3,501)
Operating loss(5,523)(13,809)
Finance income74303
Finance expenses(24)(53)
Finance result50250
Result before income taxes(5,473)(13,559)
Income taxes
Net loss for the period(5,473)(13,559)
Items not to be reclassified subsequently to profit or loss  
Remeasurement of the net defined benefit pension liability2639
Total other comprehensive profit / (loss)2639
Comprehensive loss(5,447)(13,520)
Loss per share in EUR (basic and diluted)(0.21)(0.52)
   

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, 2025 and December 31, 2024 (audited)

in kEURJune 30, 2025
(unaudited)
December 31,2024
(audited)
ASSETS  
Non-current assets  
Property, plant and equipment1924
Intangible assets831865
Right-of-use assets70100
Other non-current assets255228
Total non-current assets1,1751,217
Current assets  
Financial assets3063
Other current assets and prepayments377639
Cash and cash equivalents4,8379,365
Total current assets5,24410,067
TOTAL ASSETS6,41911,284
   
Equity  
Share capital262261
Share premium161,477161,477
Other capital reserves16,52415,777
Accumulated other comprehensive loss(242)(268)
Accumulated deficit(174,840)(169,367)
Total equity3,1817,880
Non-current liabilities  
Pension liability1,2651,317
Provisions long-term663647
Lease liability1142
Total non-current liabilities 1,9392,006
Current liabilities  
Trade payables1,0251,015
Lease liabilities6160
Other liabilities213324
Total current liabilities1,2991,399
Total Liabilities3,2383,405
TOTAL EQUITY AND LIABILITIES6,41911,284
   

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, 2025 and 2024

in kEURShare
capital
Share
premium
Other
capital reserves
Accumulated other
comprehensive
loss
Accumulated deficitTotal
equity
       
January 1, 2025261161,47715,777(268)(169,367)7,880
Net loss for the period(5,473)(5,473)
Remeasurement of the net defined benefit pension liability2626
Comprehensive loss26(5,473)(5,447)
Proceeds from the issuance of common shares11
Share-based payments747747
June 30, 2025262161,47716,524(242)(174,840)3,181
       
January 1, 202426,067135,67113,599(256)(148,799)26,282
Net loss for the period(13,559)(13,559)
Remeasurement of the net defined benefit pension liability3939
Comprehensive loss39(13,559)(13,520)
Share-based payments1,2181,218
June 30, 202426,067135,67114,817(217)(162,358)13,980
       

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, 2025 and 2024

 For the six months ended
June 30,
in kEUR2025
(unaudited)
2024
(unaudited)
   
Operating activities  
Net loss for the period(5,473)(13,559)
Adjustments for:  
Finance result(50)(250)
Depreciation and amortization7373
Share based payments7471,218
Foreign currency gain (loss) from other items than cash3(25)
Other non-cash adjustments119
Changing in:  
Financial assets(4)
Other current assets and prepayments262383
Other long-term assets(27)
Pension liabilities(47)(66)
Trade payables10(1,429)
Other liabilities(96)(13)
Interest received103353
Interest paid(2)
Cash flows used in operating activities(4,496)(13,300)
Investing activities  
Purchase of plant and equipment(4)
Proceeds from sale of financial assets10,000
Cash flows used in investing activities(4)10,000
Financing activities  
Payment of lease liabilities(30)(28)
Proceeds from the issuance of common shares2
Cash flows provided by financing activities(28)(28)
Net increase in cash and cash equivalents(4,528)(3,328)
Cash and cash equivalents at the beginning of period9,36518,562
Effect of exchange rate fluctuation on cash held38
Cash and cash equivalents at end of period4,83715,272
   

The accompanying notes are an integral part of these condensed interim financial statements.

 

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:

Investor 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

Media Contact
Trophic Communications
Valeria Fisher or Verena Schossmann
Tel: +49 175 8041816 / +49 151 219 412 77
Email: vivoryon@trophic.eu

Attachment


FAQ

What were Vivoryon's (VVY) key financial results for H1 2025?

Vivoryon reported a net loss of EUR 5.5M (down from EUR 13.6M in H1 2024), with R&D expenses of EUR 2.8M and cash position of EUR 4.8M as of June 30, 2025.

What were the main clinical developments for Vivoryon's varoglutamstat in H1 2025?

Meta-analysis of VIVIAD and VIVA-MIND studies showed significant improvement in kidney function (eGFR), with effects first observed at week 24 and sustained through week 96. Pre-clinical data also demonstrated synergistic effects with SGLT-2 inhibitors.

How long will Vivoryon's current cash reserves last?

The company's current cash position of EUR 4.8M is expected to fund operations into January 2026, without considering potential SEPA funds or additional financing.

What is the patent protection timeline for Vivoryon's varoglutamstat?

A new U.S. patent was granted providing exclusivity through 2044, with potential extension until 2049 under the Hatch-Waxman Act.

What are Vivoryon's plans for varoglutamstat's Phase 2b study in DKD?

Vivoryon plans to conduct a Phase 2b study in patients with advanced diabetic kidney disease (DKD) stage 3b/4, but initiation is subject to securing additional funding and/or partnership.
VVY

:VVY

VVY Rankings

VVY Latest News

VVY Stock Data