{"success":true,"data":{"pressRelease":{"id":"5860","rtpr_id":"nGNE9HVF0g","ticker":"05Y","exchange":"","all_tickers":["05Y"],"title":"REG-Vivoryon Therapeutics N.V. Reports Full Year 2025 Financial Results and Provides Business Update","author":"Globe Newswire","published_at":"2026-04-23T05:00:00.941Z","article_body":"Vivoryon Therapeutics N.V. Reports Full Year 2025 Financial Results \nand Provides Business Update\n* Compelling kidney function data and meta-analysis from two Phase 2 studies\nwith varoglutamstat presented at ERA 2025, ASN kidney week 2025 and at WCN\n2026\n* Analysis of data for patients with lower baseline eGFR showed consistent and\npronounced treatment effect in Phase 2 program, further supporting the\nCompany’s plans to advance development in stage 3b/4 diabetic kidney disease\n(DKD) \n* Novel composition of matter patent for varoglutamstat granted in the U.S.;\npatent term to provide exclusivity through 2044 with subsequent opportunity\nfor patent term extension\n* Successful completion of private placement supported by existing and new\nshareholders raising EUR 5.1 million\n* Updated financial guidance: Vivoryon now expects cash and cash equivalents\nto be sufficient for funding operations into Q4 2026, providing financial\nrunway and flexibility to realize strategic partnership\n* Management to host a conference call today at 3:00 pm CEST (9:00 am EDT)\nHalle (Saale) / Munich, Germany, April 23, 2026 - Vivoryon Therapeutics N.V.\n(Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company\ndeveloping small molecule medicines for inflammatory and fibrotic disorders,\nwith a primary focus on kidney diseases, today announced financial results for\nthe twelve-month period ended December 31, 2025, and provided a corporate\nupdate. The report is available on the Company’s website\nhttps://www.vivoryon.com/financial-information/.\n\n“In 2025 we further substantiated varoglutamstat’s observed effect on\nkidney function with new analyses from both the VIVIAD and VIVA-MIND Phase 2\nstudies. The results confirmed an increase in eGFR for varoglutamstat-treated\npatients compared to placebo. The beneficial effect of varoglutamstat was also\nclearly demonstrated in participants with lower baseline eGFR levels and in\nparticipants with diabetes. These results underpin our strategy to advance\nvaroglutamstat into a Phase 2 study evaluating its potential in stage 3b/4\ndiabetic kidney disease where, despite recent advances, there remains a\nsignificant unmet need for therapies that address underlying inflammation and\nstabilize kidney function,” said Frank Weber, MD, CEO of Vivoryon. \n“We have designed a focused Phase 2b study in DKD to evaluate varoglutamstat\nin our target patient population and we are very optimistic that we will\nachieve a strategic partnership to support this next development phase in the\nnear future.” \nHe concluded, “With varoglutamstat we have a first-in-class oral inhibitor\nof QPCT/L which has been shown to reduce the formation of ’active’\npro-inflammatory pyroglutamated proteins. This approach is complementary to\nexisting therapies and could become a significant new option in the management\nof kidney disease where, today, for a significant number of patients, kidney\ndialysis or transplant remain inevitable consequences of disease\nprogression.”\n\n\n\nFinancial Year 2025 and Post-Period Pipeline Updates\n\nVaroglutamstat Program\n\nVivoryon’s varoglutamstat Phase 2 program has shown highly consistent,\nstatistically significant and clinically meaningful improvement of kidney\nfunction (eGFR) versus placebo in two independent randomized double-blind\nplacebo-controlled studies, VIVIAD and VIVA-MIND. The Company is planning to\nconfirm these results in a dedicated Phase 2b clinical study in patients with\nDKD stage 3b/4. Initiation of the Phase 2b and all future studies is subject\nto additional funding and/or partnership, which Vivoryon continues to actively\nexplore.\n\nMeta-analysis of VIVIAD and VIVA-MIND study data\n* On January 14, 2025, the Company disclosed a meta-analysis of VIVIAD and\nVIVA-MIND data which confirmed that treatment with varoglutamstat at 600 mg\ntwice daily significantly improved eGFR kidney function in the overall study\npopulation. Statistically significant differences between varoglutamstat and\nplacebo were first observed at week 24 and were sustained until week 96.\n* The meta-analysis also confirmed a substantially larger effect size in study\nparticipants with diabetes compared to those without diabetes.\n* Data were presented at the 62(nd) Congress of the European Renal Association\n(ERA) in Vienna, Austria, on June 6, 2025, showing consistent improvement of\nkidney function in both studies independently, which was replicated in the\nmeta-analysis and pooled analysis.\n* Additionally, the Company presented a late-breaking poster on November 6,\n2025, at the American Society of Nephrology (ASN) Kidney Week 2025 in Houston,\nTexas, the world’s premier nephrology meeting. The poster highlighted\nfurther analyses of total population data from the VIVIAD Phase 2b study which\nrevealed a statistically significant correlation between the change from\nbaseline in pE-CCL2 serum levels at week 48 and the eGFR slope over time.\nSpecifically, a decrease in pE-CCL2 was significantly correlated with a\npositive (improved) eGFR slope on an individual participant basis.\n* Vivoryon also presented a poster at the World Congress of Nephrology (WCN)\nin Yokohama, Japan on March 28, 2026, providing an update on the growing body\nof evidence validating glutaminyl cyclases (QPCT/L) as promising targets in\nDKD.\n* Additional analyses of VIVIAD study data shows a consistent treatment effect\nacross eGFR levels in the lower eGFR percentiles. In patients with diabetes\nwithin the lower eGFR percentiles (50%/ 33.3%/ 25%/ 20%), mean eGFR baseline\nlevels ranged from 65-56 mL/min/1.73m(2) and the treatment effect was in the\nrange of 5.3-7.7 mL/min/1.73m(2)/year.\n* These results further support Vivoryon’s rationale for a dedicated Phase\n2b clinical study in patients with advanced DKD stage 3b/4.\nPre-clinical data continue to support varoglutamstat’s mechanism of action\nand potential in kidney disease\n* On April 29, 2025, Vivoryon disclosed pre-clinical data from a series of\nexperiments in a chronic kidney disease animal model, analyzing different\ntreatment regimens of varoglutamstat in combination with standard of care for\nkidney disease, the SGLT-2 inhibitor dapagliflozin. Data analysis revealed a\nsynergistic in vivo effect for the combination treatment of dapagliflozin and\nvaroglutamstat over a broad panel of markers, nearly normalizing pathology vs.\ncontrol across the three key areas of inflammation, fibrosis and kidney\nfunction. These effects suggest that QPCT/L inhibitors could be an ideal\ncombination partner for patients treated with SGLT-2 inhibitors.\n* Vivoryon has investigated the effects of varoglutamstat on inflammation,\nfibrosis and kidney function in an established advanced mouse model of DKD\nwith type 2 diabetes and hypertension (ReninAAV UNx db/db). QPCT/L\ninhibition with varoglutamstat led to a statistically significant reduction in\ninflammation (CD11c), fibrosis (glomerulosclerosis) and plasma creatinine,\nsupporting an improvement in kidney function. These data corroborate the\neffect of varoglutamstat on key kidney disease biomarkers previously reported\nin the ADI/CKD model and add to the overall body of evidence supporting\nvaroglutamstat’s potential in kidney disease including DKD.\n* The Company is actively expanding the data set around varoglutamstat’s\nmechanism of action (MOA) and recent studies further elucidate the molecular\nmechanisms underlying the substantial benefits reported from the VIVIAD and\nVIVA-MIND studies. On April 22, 2026, the Company published on its website a\npre-recorded webcast contextualizing new data around the varoglutamstat’s\nMOA. The webcast includes new data on the role of QPCT and QPCTL in\ninflammation and fibrosis, including revealing their newly discovered role in\ncollagen maturation, the disruption of which is a key factor in fibrosis, as\nwell as new data on the existing medical need in kidney disease and the\npositive effect of varoglutamstat treatment on specialized blood-filtering\nkidney cells (podocytes).] The webcast can be accessed\nhttps://www.vivoryon.com/science-insights-understanding-varoglutamstat/\nProposed clinical development plan in DKD\n\nVivoryon’s key strategic priority for 2026 is to secure the funding\nnecessary to advance varoglutamstat in kidney disease and confirm the\npreviously reported compelling data from two independent Phase 2 studies,\nVIVIAD and VIVA-MIND, in the target population by conducting a Phase 2b\nclinical study in patients with advanced DKD stage 3b/4. Initiation of the\nPhase 2b and all future studies is subject to additional funding and/or\npartnership, which Vivoryon continues to actively explore.\n\nExpanded intellectual property portfolio in kidney disease treatment\nVivoryon announced on May 27, 2025, that the United States Patent and\nTrademark Office (USPTO) granted an additional patent covering the active\npolymorph of varoglutamstat. The U.S. patent (US 12,312,335) was granted after\nan accelerated examination process and has a scheduled runtime through 2044\nwith subsequent opportunity for patent term extension of up to five years to\n2049 under the Hatch-Waxman Act. Additional patent applications covering\nmedical use and dosing regimens for varoglutamstat and related structures in\nkidney disease as monotherapy and in combination with SGLT-2 inhibitors are\ncurrently under examination by the relevant patent authorities.\n\nPipeline Updates: Early-stage Pipeline\n\nIn 2025, the Company enlarged its portfolio by nominating a novel, next\ngeneration QPCT/L inhibitor showing compelling pharmacological activity. This\ncandidate, VY2149, is a potential fast follower in DKD or could also be\nexplored for other inflammatory and fibrotic diseases including orphan\ndiseases and chronic kidney disease (CKD). VY2149 is currently in pre-clinical\nstage and further development is subject to additional funding and/or\npartnership, which Vivoryon continues to actively explore.\n\nFinancial Year 2025 Corporate Updates\n* In April 2025, Vivoryon entered into a Standby Equity Purchase Agreement\n(SEPA) with Yorkville Advisors Global, LP, allowing for the purchase of up to\nEUR 15 million in ordinary shares over the subsequent 36 months. Under the\nterms of this agreement, Yorkville has committed to acquiring these shares,\nproviding Vivoryon with the right, but not the obligation, to sell them in\nindividual tranches while excluding existing shareholders’ pre-emptive\nrights. As of today, Vivoryon has not initiated any tranches of the SEPA.\n* In May 2025, Julia Neugebauer, PhD, assumed the newly created role of Chief\nOperating Officer (COO) of Vivoryon, heading investor relations and\ncommunications activities, spearheading market analysis, and overseeing\nvarious corporate functions.\n* In June 2025, Vivoryon held its 2025 Annual General Meeting (AGM) in\nAmsterdam, the Netherlands. The shareholders approved all items on the agenda\nof the meeting.\n* In October 2025, Vivoryon successfully completed a private placement raising\nEUR 5.1 million by issuing 3,380,500 new shares at a purchase price of EUR\n1.50 per new share. The placement was supported by existing and new\nshareholders, providing the financial runway and flexibility to realize\nstrategic partnership for varoglutamstat in chronic kidney disease.\n* In December 2025, Marcus Irsfeld took over the role of Chief Financial\nOfficer (CFO) of Vivoryon from Anne Doering, CFA, who stepped down in December\n2025. Mr. Irsfeld is expected to stand for election as executive member of the\nCompany’s Board at the 2026 Annual General Meeting.\n\n\nFinancial Results for the Full Year 2025\n\nNo Revenues were generated in 2025.\n\nResearch and development expenses decreased by EUR 9.7 million to EUR 4.4\nmillion in the year ended December 31, 2025, compared to EUR 14.1 million in\nthe previous year. This decrease is primarily attributable to EUR 9.3 million\nlower third-party expenses due to the ramp-down of the Phase 2b clinical\nstudies VIVIAD and VIVA-MIND, namely a reduction in clinical costs of EUR 7.0\nmillion and EUR 1.7 million lower manufacturing costs.\n\nGeneral and administrative expenses were EUR 4.8 million in the year ended\nDecember 31, 2025, compared to EUR 6.9 million in 2024. The decrease by\nEUR 2.1 million was largely attributable to lower expenses for personnel\n(EUR 1.1 million) and other legal costs (EUR 0.6 million). The cost decrease\nin personnel was predominantly caused by the decrease in share-option expenses\n(EUR 1.0 million).\n\nThe net loss for the year ended December 31, 2025 was EUR 8.9 million\ncompared to EUR 20.6 million in the year ended December 31, 2024.\n\nAs of December 31, 2025, Vivoryon held cash and cash equivalents of EUR 5.6\nmillion compared to cash and cash equivalents of EUR 9.4 million as of\nDecember 31, 2024.\n\nCash flows used in operating activities were EUR 8.5 million in the year\nended December 31, 2025, compared to EUR 19.2 million in the year ended\nDecember 31, 2024.\n\nCash flows provided by / used in (-) investing activities were negligible in\nthe year ended December 31, 2025, compared to EUR 10 million provided by\ninvesting activities in the year ended December 31, 2024.\n\nCash flows provided by / used in (-) financing activities were EUR 4.7\nmillion for the year 2025 compared to cash flows used in financing activities\nof EUR -0.1 million in 2024.\n\nOutlook & financial guidance\n\nThe Company expects, based on its most recent financial and business plan,\nthat its existing cash and cash equivalents will be sufficient to fund its\noperating plans into the fourth quarter of 2026, subject to the occurrence of\nunforeseen circumstances and without taking into account any funds from the\nSEPA as well as other potential additional financing transactions, if any.\n\nThis cash runway guidance reflects an overall reduction in cash utilization\nwhile prudently investing in preparing to execute on the Company’s kidney\ndisease strategy. The initiation of the Phase 2b DKD study and all future\nstudies is subject to further additional funding and/or partnership, which the\nCompany continues to actively explore.\n\nThe viability of the Company’s business beyond its current guidance is\ndependent on its ability to raise additional funds to finance its operations\nwhich also depends on the success of its research and development activities\nsuch as those focusing on exploring opportunities in kidney disease.\n\nThe financial statements have been prepared on the basis that the Company will\ncontinue as a going concern. The Company expects to have continued operating\nlosses for the foreseeable future and the need to raise additional capital to\nfinance its future operations, and, as of April 23, 2026, the Company has\nconcluded that the ability to continue as a going concern in the financial\nyear 2026 depends on the ability to generate additional funding. Please refer\nto the Company’s Annual Report 2025 for further information.\n\n\n\nConference call and webcast\n\nVivoryon will host a conference call and webcast today, April 23, 2026, at\n3:00 pm CEST (9:00 am EDT). A Q&A session will follow the presentation of the\nfull year results.\n\nA live webcast and slides will be made available at:\nhttps://www.vivoryon.com/news-and-events/presentations-webcasts/\n\nTo join the conference call via phone, participants may pre-register and will\nreceive dedicated dial-in details to easily and quickly access the call via\nthe following website:\nhttps://register-conf.media-server.com/register/BIf6c6c97fd8e04610aca204505327e259\n\nIt is suggested participants dial into the conference call 15 minutes prior to\nthe scheduled start time to avoid any delays in attendance.\n\nApproximately one day after the call, a slide-synchronized audio replay of the\nconference will be available on:\nhttps://www.vivoryon.com/news-and-events/presentations-webcasts/   \n\n###\n\nVivoryon Therapeutics N.V. Financial Statements\nStatement of Operations and Comprehensive Loss for the Years Ended December\n31, 2025 and 2024\n\n in kEUR, except for share data 2025 2024 \n Research and development expenses (4,381) (14,058) \n General and administrative expenses (4,796) (6,903) \n Other operating income 265 — \n Other operating expense — (3) \n Operating loss (8,912) (20,964) \n Finance income 106 482 \n Finance expense (47) (86) \n Finance result 59 396 \n Result before income taxes (8,853) (20,568) \n Income taxes — — \n Net loss for the period (8,853) (20,568) \n Items not to be reclassified subsequently to profit or loss \n Remeasurement of the net defined benefit pension liability 32 (12) \n Total other comprehensive (loss) / income 32 (12) \n Comprehensive loss (8,821) (20,580) \n Loss per share in EUR (basic and diluted) (0.33) (0.79) \n\nThe accompanying notes are an integral part of these financial statements.\n\n\n\nVivoryon Therapeutics N.V.\nStatements of Financial Position as of December 31, 2025, and 2024\n\n in kEUR 2025 2024 \n ASSETS \n Non-current assets \n Property, plant and equipment 13 24 \n Intangible assets 797 865 \n Right-of-use assets 108 100 \n Other non-current assets 173 228 \n Total non-current assets 1,091 1,217 \n Current assets \n Financial assets 33 63 \n Other current assets and prepayments 775 639 \n Cash and cash equivalents 5,619 9,365 \n Total current assets 6,427 10,067 \n TOTAL ASSETS 7,518 11,284 \n \n Equity \n Share capital 296 261 \n Share premium 166,218 161,477 \n Other capital reserves 16,670 15,777 \n Accumulated other comprehensive loss (237) (268) \n Accumulated deficit (178,220) (169,367) \n Total equity 4,727 7,880 \n Non-current liabilities \n Pension liability 1,232 1,317 \n Provisions long-term 678 647 \n Lease liabilities 44 42 \n Total non-current liabilities 1,954 2,006 \n Current liabilities \n Trade payables 458 1,015 \n Lease liabilities 64 60 \n Other liabilities 315 324 \n Total current liabilities 837 1,399 \n Total Liabilities 2,791 3,405 \n TOTAL EQUITY AND LIABILITIES 7,518 11,284 \n\nThe accompanying notes are an integral part of these financial statements.\n\n\n\nVivoryon Therapeutics N.V.\nStatements of Changes in Shareholders’ Equity for the Years Ended December\n31, 2025, and 2024\n\n in kEUR Share capital Share premium Other capital reserves Accumulated other comprehen-sive loss Accumulated deficit Total equity \n January 1, 2024 26,067 135,671 13,599 (256) (148,799) 26,282 \n Net loss for the period — — — — (20,568) (20,568) \n Remeasurement of the net defined benefit pension liability — — — (12) — (12) \n Comprehensive (loss) / income — — — (12) (20,568) (20,580) \n Capital (decrease) / increase (25,806) 25,806 — — — — \n Share-based payments — — 2,178 — — 2,178 \n December 31, 2024 261 161,477 15,777 (268) (169,367) 7,880 \n Net loss for the period — — — — (8,853) (8,853) \n Remeasurement of the net defined benefit pension liability — — — 32 — 32 \n Comprehensive (loss) / income — — — 32 (8,853 ) (8,821 ) \n Proceeds from the issuance of common shares 35 5,037 — — — 5,072 \n Transaction costs of equity transactions — (296) — — — (296) \n Share-based payments — — 893 — — 893 \n December 31, 2025 296 166,218 16,670 (237) (178,220) 4,727 \n\nThe accompanying notes are an integral part of these financial statements.\n\n\n\nVivoryon Therapeutics N.V. \nStatements of Cash Flows for the Years ended December 31, 2025, and 2024\n\n in kEUR 2025 2024 \n Operating activities \n Net loss for the period (8,853) (20,568) \n Adjustments for: \n Finance result (59) (396) \n Depreciation and amortization 147 147 \n Share based payments 893 2,178 \n Deferred income tax — — \n Provisions 31 635 \n Other non-cash adjustments (2) 4 \n Changing in \n Other current and non-current assets and prepayments (81) 218 \n Pension liabilities (95) (94) \n Trade payables (554) (1,899) \n Other liabilities (9) 76 \n Interest received 130 526 \n Interest paid (3) (1) \n Cash flows used in operating activities (8,455) (19,174) \n Investing activities \n Purchase of plant and equipment (6) (2) \n Purchase of intangible assets — — \n Purchase of financial assets — — \n Proceeds from sale of financial assets — 10,000 \n Cash flows used in investing activities (6) 9,998 \n Financing activities \n Proceeds from the issuance of common shares 5,072 — \n Transaction costs of equity transactions (296) — \n Payment of lease liabilities (61) (57) \n Cash flows provided by / (used in) financing activities 4,715 (57) \n Net decrease in cash and cash equivalents (3,746) (9,233) \n Cash and cash equivalents at the beginning of period 9,365 18,562 \n Effect of exchange rate fluctuation on cash held — 36 \n Cash and cash equivalents at the end of period 5,619 9,365 \n\nThe accompanying notes are an integral part of these financial statements.\n\n\n\nAnnual Financial Report 2025\n\nThe financial statements of Vivoryon have been prepared in accordance with\nInternational Financial Reporting Standards (IFRS) of the International\nAccounting Standards Board, as adopted by the European Union (EU-IFRS) and\nwith Section 2:362(9) of the Netherlands Civil Code. The auditor KPMG has\nissued an unqualified auditor's report for both statements. The reports are\navailable on the Company’s website www.vivoryon.com.\n\n\n\n###\n\n\n\nAbout Vivoryon Therapeutics N.V.\nVivoryon is a clinical stage biotechnology company focused on developing\ninnovative small molecule-based medicines for the treatment of inflammatory\nand fibrotic disorders of the kidney. Driven by its passion for\nground-breaking science and innovation, the Company strives to improve patient\noutcomes by changing the course of severe diseases through modulating the\nactivity and stability of pathologically relevant proteins. Vivoryon’s most\nadvanced program, varoglutamstat, a proprietary, first-in-class orally\navailable QPCT/L inhibitor, is being evaluated to treat diabetic kidney\ndisease. www.vivoryon.com\n\nVivoryon Forward Looking Statements\nThis press release includes forward-looking statements, including, without\nlimitation, those regarding the business strategy, management plans and\nobjectives for future operations of Vivoryon Therapeutics N.V. (the\n“Company”), estimates and projections with respect to the market for the\nCompany’s products and forecasts and statements as to when the Company’s\nproducts may be available. Words such as “anticipate,” “believe,”\n“estimate,” “expect,” “forecast,” “intend,” “may,”\n“plan,” “project,” “predict,” “should” and “will” and\nsimilar expressions as they relate to the Company are intended to identify\nsuch forward-looking statements. These forward-looking statements are not\nguarantees of future performance; rather they are based on the Management’s\ncurrent expectations and assumptions about future events and trends, the\neconomy and other future conditions. The forward-looking statements involve a\nnumber of known and unknown risks and uncertainties. These risks and\nuncertainties and other factors could materially adversely affect the outcome\nand financial effects of the plans and events described herein. The\nCompany’s results of operations, cash needs, financial condition, liquidity,\nprospects, future transactions, strategies or events may differ materially\nfrom those expressed or implied in such forward-looking statements and from\nexpectations. As a result, no undue reliance should be placed on such\nforward-looking statements. This press release does not contain risk factors.\nCertain risk factors that may affect the Company’s future financial results\nare discussed in the published annual financial statements of the Company.\nThis press release, including any forward-looking statements, speaks only as\nof the date of this press release. The Company does not assume any obligation\nto update any information or forward-looking statements contained herein, save\nfor any information required to be disclosed by law.\n\nFor more information, please contact:\n\nVivoryon Therapeutics N.V.\nDr. Manuela Bader, Director IR & Communication\nEmail: IR@vivoryon.com\n\nLifeSci Advisors\nSandya von der Weid \nTel: +41 78 680 05 38 \nEmail: svonderweid@lifesciadvisors.com\n\nAttachment\n* 2026-04-23_VVY_FY2025\n(https://ml-eu.globenewswire.com/Resource/Download/65b8f532-e685-48a9-a6c7-c7517508aeaa)","article_body_html":"","raw_payload":{"data":{"id":"nGNE9HVF0g","title":"REG-Vivoryon Therapeutics N.V. Reports Full Year 2025 Financial Results and Provides Business Update","author":"Globe Newswire","ticker":"05Y","created":"2026-04-23T05:00:00.941Z","tickers":["05Y"],"exchange":"","article_body":"Vivoryon Therapeutics N.V. Reports Full Year 2025 Financial Results \nand Provides Business Update\n* Compelling kidney function data and meta-analysis from two Phase 2 studies\nwith varoglutamstat presented at ERA 2025, ASN kidney week 2025 and at WCN\n2026\n* Analysis of data for patients with lower baseline eGFR showed consistent and\npronounced treatment effect in Phase 2 program, further supporting the\nCompany’s plans to advance development in stage 3b/4 diabetic kidney disease\n(DKD) \n* Novel composition of matter patent for varoglutamstat granted in the U.S.;\npatent term to provide exclusivity through 2044 with subsequent opportunity\nfor patent term extension\n* Successful completion of private placement supported by existing and new\nshareholders raising EUR 5.1 million\n* Updated financial guidance: Vivoryon now expects cash and cash equivalents\nto be sufficient for funding operations into Q4 2026, providing financial\nrunway and flexibility to realize strategic partnership\n* Management to host a conference call today at 3:00 pm CEST (9:00 am EDT)\nHalle (Saale) / Munich, Germany, April 23, 2026 - Vivoryon Therapeutics N.V.\n(Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company\ndeveloping small molecule medicines for inflammatory and fibrotic disorders,\nwith a primary focus on kidney diseases, today announced financial results for\nthe twelve-month period ended December 31, 2025, and provided a corporate\nupdate. The report is available on the Company’s website\nhttps://www.vivoryon.com/financial-information/.\n\n“In 2025 we further substantiated varoglutamstat’s observed effect on\nkidney function with new analyses from both the VIVIAD and VIVA-MIND Phase 2\nstudies. The results confirmed an increase in eGFR for varoglutamstat-treated\npatients compared to placebo. The beneficial effect of varoglutamstat was also\nclearly demonstrated in participants with lower baseline eGFR levels and in\nparticipants with diabetes. These results underpin our strategy to advance\nvaroglutamstat into a Phase 2 study evaluating its potential in stage 3b/4\ndiabetic kidney disease where, despite recent advances, there remains a\nsignificant unmet need for therapies that address underlying inflammation and\nstabilize kidney function,” said Frank Weber, MD, CEO of Vivoryon. \n“We have designed a focused Phase 2b study in DKD to evaluate varoglutamstat\nin our target patient population and we are very optimistic that we will\nachieve a strategic partnership to support this next development phase in the\nnear future.” \nHe concluded, “With varoglutamstat we have a first-in-class oral inhibitor\nof QPCT/L which has been shown to reduce the formation of ’active’\npro-inflammatory pyroglutamated proteins. This approach is complementary to\nexisting therapies and could become a significant new option in the management\nof kidney disease where, today, for a significant number of patients, kidney\ndialysis or transplant remain inevitable consequences of disease\nprogression.”\n\n\n\nFinancial Year 2025 and Post-Period Pipeline Updates\n\nVaroglutamstat Program\n\nVivoryon’s varoglutamstat Phase 2 program has shown highly consistent,\nstatistically significant and clinically meaningful improvement of kidney\nfunction (eGFR) versus placebo in two independent randomized double-blind\nplacebo-controlled studies, VIVIAD and VIVA-MIND. The Company is planning to\nconfirm these results in a dedicated Phase 2b clinical study in patients with\nDKD stage 3b/4. Initiation of the Phase 2b and all future studies is subject\nto additional funding and/or partnership, which Vivoryon continues to actively\nexplore.\n\nMeta-analysis of VIVIAD and VIVA-MIND study data\n* On January 14, 2025, the Company disclosed a meta-analysis of VIVIAD and\nVIVA-MIND data which confirmed that treatment with varoglutamstat at 600 mg\ntwice daily significantly improved eGFR kidney function in the overall study\npopulation. Statistically significant differences between varoglutamstat and\nplacebo were first observed at week 24 and were sustained until week 96.\n* The meta-analysis also confirmed a substantially larger effect size in study\nparticipants with diabetes compared to those without diabetes.\n* Data were presented at the 62(nd) Congress of the European Renal Association\n(ERA) in Vienna, Austria, on June 6, 2025, showing consistent improvement of\nkidney function in both studies independently, which was replicated in the\nmeta-analysis and pooled analysis.\n* Additionally, the Company presented a late-breaking poster on November 6,\n2025, at the American Society of Nephrology (ASN) Kidney Week 2025 in Houston,\nTexas, the world’s premier nephrology meeting. The poster highlighted\nfurther analyses of total population data from the VIVIAD Phase 2b study which\nrevealed a statistically significant correlation between the change from\nbaseline in pE-CCL2 serum levels at week 48 and the eGFR slope over time.\nSpecifically, a decrease in pE-CCL2 was significantly correlated with a\npositive (improved) eGFR slope on an individual participant basis.\n* Vivoryon also presented a poster at the World Congress of Nephrology (WCN)\nin Yokohama, Japan on March 28, 2026, providing an update on the growing body\nof evidence validating glutaminyl cyclases (QPCT/L) as promising targets in\nDKD.\n* Additional analyses of VIVIAD study data shows a consistent treatment effect\nacross eGFR levels in the lower eGFR percentiles. In patients with diabetes\nwithin the lower eGFR percentiles (50%/ 33.3%/ 25%/ 20%), mean eGFR baseline\nlevels ranged from 65-56 mL/min/1.73m(2) and the treatment effect was in the\nrange of 5.3-7.7 mL/min/1.73m(2)/year.\n* These results further support Vivoryon’s rationale for a dedicated Phase\n2b clinical study in patients with advanced DKD stage 3b/4.\nPre-clinical data continue to support varoglutamstat’s mechanism of action\nand potential in kidney disease\n* On April 29, 2025, Vivoryon disclosed pre-clinical data from a series of\nexperiments in a chronic kidney disease animal model, analyzing different\ntreatment regimens of varoglutamstat in combination with standard of care for\nkidney disease, the SGLT-2 inhibitor dapagliflozin. Data analysis revealed a\nsynergistic in vivo effect for the combination treatment of dapagliflozin and\nvaroglutamstat over a broad panel of markers, nearly normalizing pathology vs.\ncontrol across the three key areas of inflammation, fibrosis and kidney\nfunction. These effects suggest that QPCT/L inhibitors could be an ideal\ncombination partner for patients treated with SGLT-2 inhibitors.\n* Vivoryon has investigated the effects of varoglutamstat on inflammation,\nfibrosis and kidney function in an established advanced mouse model of DKD\nwith type 2 diabetes and hypertension (ReninAAV UNx db/db). QPCT/L\ninhibition with varoglutamstat led to a statistically significant reduction in\ninflammation (CD11c), fibrosis (glomerulosclerosis) and plasma creatinine,\nsupporting an improvement in kidney function. These data corroborate the\neffect of varoglutamstat on key kidney disease biomarkers previously reported\nin the ADI/CKD model and add to the overall body of evidence supporting\nvaroglutamstat’s potential in kidney disease including DKD.\n* The Company is actively expanding the data set around varoglutamstat’s\nmechanism of action (MOA) and recent studies further elucidate the molecular\nmechanisms underlying the substantial benefits reported from the VIVIAD and\nVIVA-MIND studies. On April 22, 2026, the Company published on its website a\npre-recorded webcast contextualizing new data around the varoglutamstat’s\nMOA. The webcast includes new data on the role of QPCT and QPCTL in\ninflammation and fibrosis, including revealing their newly discovered role in\ncollagen maturation, the disruption of which is a key factor in fibrosis, as\nwell as new data on the existing medical need in kidney disease and the\npositive effect of varoglutamstat treatment on specialized blood-filtering\nkidney cells (podocytes).] The webcast can be accessed\nhttps://www.vivoryon.com/science-insights-understanding-varoglutamstat/\nProposed clinical development plan in DKD\n\nVivoryon’s key strategic priority for 2026 is to secure the funding\nnecessary to advance varoglutamstat in kidney disease and confirm the\npreviously reported compelling data from two independent Phase 2 studies,\nVIVIAD and VIVA-MIND, in the target population by conducting a Phase 2b\nclinical study in patients with advanced DKD stage 3b/4. Initiation of the\nPhase 2b and all future studies is subject to additional funding and/or\npartnership, which Vivoryon continues to actively explore.\n\nExpanded intellectual property portfolio in kidney disease treatment\nVivoryon announced on May 27, 2025, that the United States Patent and\nTrademark Office (USPTO) granted an additional patent covering the active\npolymorph of varoglutamstat. The U.S. patent (US 12,312,335) was granted after\nan accelerated examination process and has a scheduled runtime through 2044\nwith subsequent opportunity for patent term extension of up to five years to\n2049 under the Hatch-Waxman Act. Additional patent applications covering\nmedical use and dosing regimens for varoglutamstat and related structures in\nkidney disease as monotherapy and in combination with SGLT-2 inhibitors are\ncurrently under examination by the relevant patent authorities.\n\nPipeline Updates: Early-stage Pipeline\n\nIn 2025, the Company enlarged its portfolio by nominating a novel, next\ngeneration QPCT/L inhibitor showing compelling pharmacological activity. This\ncandidate, VY2149, is a potential fast follower in DKD or could also be\nexplored for other inflammatory and fibrotic diseases including orphan\ndiseases and chronic kidney disease (CKD). VY2149 is currently in pre-clinical\nstage and further development is subject to additional funding and/or\npartnership, which Vivoryon continues to actively explore.\n\nFinancial Year 2025 Corporate Updates\n* In April 2025, Vivoryon entered into a Standby Equity Purchase Agreement\n(SEPA) with Yorkville Advisors Global, LP, allowing for the purchase of up to\nEUR 15 million in ordinary shares over the subsequent 36 months. Under the\nterms of this agreement, Yorkville has committed to acquiring these shares,\nproviding Vivoryon with the right, but not the obligation, to sell them in\nindividual tranches while excluding existing shareholders’ pre-emptive\nrights. As of today, Vivoryon has not initiated any tranches of the SEPA.\n* In May 2025, Julia Neugebauer, PhD, assumed the newly created role of Chief\nOperating Officer (COO) of Vivoryon, heading investor relations and\ncommunications activities, spearheading market analysis, and overseeing\nvarious corporate functions.\n* In June 2025, Vivoryon held its 2025 Annual General Meeting (AGM) in\nAmsterdam, the Netherlands. The shareholders approved all items on the agenda\nof the meeting.\n* In October 2025, Vivoryon successfully completed a private placement raising\nEUR 5.1 million by issuing 3,380,500 new shares at a purchase price of EUR\n1.50 per new share. The placement was supported by existing and new\nshareholders, providing the financial runway and flexibility to realize\nstrategic partnership for varoglutamstat in chronic kidney disease.\n* In December 2025, Marcus Irsfeld took over the role of Chief Financial\nOfficer (CFO) of Vivoryon from Anne Doering, CFA, who stepped down in December\n2025. Mr. Irsfeld is expected to stand for election as executive member of the\nCompany’s Board at the 2026 Annual General Meeting.\n\n\nFinancial Results for the Full Year 2025\n\nNo Revenues were generated in 2025.\n\nResearch and development expenses decreased by EUR 9.7 million to EUR 4.4\nmillion in the year ended December 31, 2025, compared to EUR 14.1 million in\nthe previous year. This decrease is primarily attributable to EUR 9.3 million\nlower third-party expenses due to the ramp-down of the Phase 2b clinical\nstudies VIVIAD and VIVA-MIND, namely a reduction in clinical costs of EUR 7.0\nmillion and EUR 1.7 million lower manufacturing costs.\n\nGeneral and administrative expenses were EUR 4.8 million in the year ended\nDecember 31, 2025, compared to EUR 6.9 million in 2024. The decrease by\nEUR 2.1 million was largely attributable to lower expenses for personnel\n(EUR 1.1 million) and other legal costs (EUR 0.6 million). The cost decrease\nin personnel was predominantly caused by the decrease in share-option expenses\n(EUR 1.0 million).\n\nThe net loss for the year ended December 31, 2025 was EUR 8.9 million\ncompared to EUR 20.6 million in the year ended December 31, 2024.\n\nAs of December 31, 2025, Vivoryon held cash and cash equivalents of EUR 5.6\nmillion compared to cash and cash equivalents of EUR 9.4 million as of\nDecember 31, 2024.\n\nCash flows used in operating activities were EUR 8.5 million in the year\nended December 31, 2025, compared to EUR 19.2 million in the year ended\nDecember 31, 2024.\n\nCash flows provided by / used in (-) investing activities were negligible in\nthe year ended December 31, 2025, compared to EUR 10 million provided by\ninvesting activities in the year ended December 31, 2024.\n\nCash flows provided by / used in (-) financing activities were EUR 4.7\nmillion for the year 2025 compared to cash flows used in financing activities\nof EUR -0.1 million in 2024.\n\nOutlook & financial guidance\n\nThe Company expects, based on its most recent financial and business plan,\nthat its existing cash and cash equivalents will be sufficient to fund its\noperating plans into the fourth quarter of 2026, subject to the occurrence of\nunforeseen circumstances and without taking into account any funds from the\nSEPA as well as other potential additional financing transactions, if any.\n\nThis cash runway guidance reflects an overall reduction in cash utilization\nwhile prudently investing in preparing to execute on the Company’s kidney\ndisease strategy. The initiation of the Phase 2b DKD study and all future\nstudies is subject to further additional funding and/or partnership, which the\nCompany continues to actively explore.\n\nThe viability of the Company’s business beyond its current guidance is\ndependent on its ability to raise additional funds to finance its operations\nwhich also depends on the success of its research and development activities\nsuch as those focusing on exploring opportunities in kidney disease.\n\nThe financial statements have been prepared on the basis that the Company will\ncontinue as a going concern. The Company expects to have continued operating\nlosses for the foreseeable future and the need to raise additional capital to\nfinance its future operations, and, as of April 23, 2026, the Company has\nconcluded that the ability to continue as a going concern in the financial\nyear 2026 depends on the ability to generate additional funding. Please refer\nto the Company’s Annual Report 2025 for further information.\n\n\n\nConference call and webcast\n\nVivoryon will host a conference call and webcast today, April 23, 2026, at\n3:00 pm CEST (9:00 am EDT). A Q&A session will follow the presentation of the\nfull year results.\n\nA live webcast and slides will be made available at:\nhttps://www.vivoryon.com/news-and-events/presentations-webcasts/\n\nTo join the conference call via phone, participants may pre-register and will\nreceive dedicated dial-in details to easily and quickly access the call via\nthe following website:\nhttps://register-conf.media-server.com/register/BIf6c6c97fd8e04610aca204505327e259\n\nIt is suggested participants dial into the conference call 15 minutes prior to\nthe scheduled start time to avoid any delays in attendance.\n\nApproximately one day after the call, a slide-synchronized audio replay of the\nconference will be available on:\nhttps://www.vivoryon.com/news-and-events/presentations-webcasts/   \n\n###\n\nVivoryon Therapeutics N.V. Financial Statements\nStatement of Operations and Comprehensive Loss for the Years Ended December\n31, 2025 and 2024\n\n in kEUR, except for share data 2025 2024 \n Research and development expenses (4,381) (14,058) \n General and administrative expenses (4,796) (6,903) \n Other operating income 265 — \n Other operating expense — (3) \n Operating loss (8,912) (20,964) \n Finance income 106 482 \n Finance expense (47) (86) \n Finance result 59 396 \n Result before income taxes (8,853) (20,568) \n Income taxes — — \n Net loss for the period (8,853) (20,568) \n Items not to be reclassified subsequently to profit or loss \n Remeasurement of the net defined benefit pension liability 32 (12) \n Total other comprehensive (loss) / income 32 (12) \n Comprehensive loss (8,821) (20,580) \n Loss per share in EUR (basic and diluted) (0.33) (0.79) \n\nThe accompanying notes are an integral part of these financial statements.\n\n\n\nVivoryon Therapeutics N.V.\nStatements of Financial Position as of December 31, 2025, and 2024\n\n in kEUR 2025 2024 \n ASSETS \n Non-current assets \n Property, plant and equipment 13 24 \n Intangible assets 797 865 \n Right-of-use assets 108 100 \n Other non-current assets 173 228 \n Total non-current assets 1,091 1,217 \n Current assets \n Financial assets 33 63 \n Other current assets and prepayments 775 639 \n Cash and cash equivalents 5,619 9,365 \n Total current assets 6,427 10,067 \n TOTAL ASSETS 7,518 11,284 \n \n Equity \n Share capital 296 261 \n Share premium 166,218 161,477 \n Other capital reserves 16,670 15,777 \n Accumulated other comprehensive loss (237) (268) \n Accumulated deficit (178,220) (169,367) \n Total equity 4,727 7,880 \n Non-current liabilities \n Pension liability 1,232 1,317 \n Provisions long-term 678 647 \n Lease liabilities 44 42 \n Total non-current liabilities 1,954 2,006 \n Current liabilities \n Trade payables 458 1,015 \n Lease liabilities 64 60 \n Other liabilities 315 324 \n Total current liabilities 837 1,399 \n Total Liabilities 2,791 3,405 \n TOTAL EQUITY AND LIABILITIES 7,518 11,284 \n\nThe accompanying notes are an integral part of these financial statements.\n\n\n\nVivoryon Therapeutics N.V.\nStatements of Changes in Shareholders’ Equity for the Years Ended December\n31, 2025, and 2024\n\n in kEUR Share capital Share premium Other capital reserves Accumulated other comprehen-sive loss Accumulated deficit Total equity \n January 1, 2024 26,067 135,671 13,599 (256) (148,799) 26,282 \n Net loss for the period — — — — (20,568) (20,568) \n Remeasurement of the net defined benefit pension liability — — — (12) — (12) \n Comprehensive (loss) / income — — — (12) (20,568) (20,580) \n Capital (decrease) / increase (25,806) 25,806 — — — — \n Share-based payments — — 2,178 — — 2,178 \n December 31, 2024 261 161,477 15,777 (268) (169,367) 7,880 \n Net loss for the period — — — — (8,853) (8,853) \n Remeasurement of the net defined benefit pension liability — — — 32 — 32 \n Comprehensive (loss) / income — — — 32 (8,853 ) (8,821 ) \n Proceeds from the issuance of common shares 35 5,037 — — — 5,072 \n Transaction costs of equity transactions — (296) — — — (296) \n Share-based payments — — 893 — — 893 \n December 31, 2025 296 166,218 16,670 (237) (178,220) 4,727 \n\nThe accompanying notes are an integral part of these financial statements.\n\n\n\nVivoryon Therapeutics N.V. \nStatements of Cash Flows for the Years ended December 31, 2025, and 2024\n\n in kEUR 2025 2024 \n Operating activities \n Net loss for the period (8,853) (20,568) \n Adjustments for: \n Finance result (59) (396) \n Depreciation and amortization 147 147 \n Share based payments 893 2,178 \n Deferred income tax — — \n Provisions 31 635 \n Other non-cash adjustments (2) 4 \n Changing in \n Other current and non-current assets and prepayments (81) 218 \n Pension liabilities (95) (94) \n Trade payables (554) (1,899) \n Other liabilities (9) 76 \n Interest received 130 526 \n Interest paid (3) (1) \n Cash flows used in operating activities (8,455) (19,174) \n Investing activities \n Purchase of plant and equipment (6) (2) \n Purchase of intangible assets — — \n Purchase of financial assets — — \n Proceeds from sale of financial assets — 10,000 \n Cash flows used in investing activities (6) 9,998 \n Financing activities \n Proceeds from the issuance of common shares 5,072 — \n Transaction costs of equity transactions (296) — \n Payment of lease liabilities (61) (57) \n Cash flows provided by / (used in) financing activities 4,715 (57) \n Net decrease in cash and cash equivalents (3,746) (9,233) \n Cash and cash equivalents at the beginning of period 9,365 18,562 \n Effect of exchange rate fluctuation on cash held — 36 \n Cash and cash equivalents at the end of period 5,619 9,365 \n\nThe accompanying notes are an integral part of these financial statements.\n\n\n\nAnnual Financial Report 2025\n\nThe financial statements of Vivoryon have been prepared in accordance with\nInternational Financial Reporting Standards (IFRS) of the International\nAccounting Standards Board, as adopted by the European Union (EU-IFRS) and\nwith Section 2:362(9) of the Netherlands Civil Code. The auditor KPMG has\nissued an unqualified auditor's report for both statements. The reports are\navailable on the Company’s website www.vivoryon.com.\n\n\n\n###\n\n\n\nAbout Vivoryon Therapeutics N.V.\nVivoryon is a clinical stage biotechnology company focused on developing\ninnovative small molecule-based medicines for the treatment of inflammatory\nand fibrotic disorders of the kidney. Driven by its passion for\nground-breaking science and innovation, the Company strives to improve patient\noutcomes by changing the course of severe diseases through modulating the\nactivity and stability of pathologically relevant proteins. Vivoryon’s most\nadvanced program, varoglutamstat, a proprietary, first-in-class orally\navailable QPCT/L inhibitor, is being evaluated to treat diabetic kidney\ndisease. www.vivoryon.com\n\nVivoryon Forward Looking Statements\nThis press release includes forward-looking statements, including, without\nlimitation, those regarding the business strategy, management plans and\nobjectives for future operations of Vivoryon Therapeutics N.V. (the\n“Company”), estimates and projections with respect to the market for the\nCompany’s products and forecasts and statements as to when the Company’s\nproducts may be available. Words such as “anticipate,” “believe,”\n“estimate,” “expect,” “forecast,” “intend,” “may,”\n“plan,” “project,” “predict,” “should” and “will” and\nsimilar expressions as they relate to the Company are intended to identify\nsuch forward-looking statements. These forward-looking statements are not\nguarantees of future performance; rather they are based on the Management’s\ncurrent expectations and assumptions about future events and trends, the\neconomy and other future conditions. The forward-looking statements involve a\nnumber of known and unknown risks and uncertainties. These risks and\nuncertainties and other factors could materially adversely affect the outcome\nand financial effects of the plans and events described herein. The\nCompany’s results of operations, cash needs, financial condition, liquidity,\nprospects, future transactions, strategies or events may differ materially\nfrom those expressed or implied in such forward-looking statements and from\nexpectations. As a result, no undue reliance should be placed on such\nforward-looking statements. This press release does not contain risk factors.\nCertain risk factors that may affect the Company’s future financial results\nare discussed in the published annual financial statements of the Company.\nThis press release, including any forward-looking statements, speaks only as\nof the date of this press release. The Company does not assume any obligation\nto update any information or forward-looking statements contained herein, save\nfor any information required to be disclosed by law.\n\nFor more information, please contact:\n\nVivoryon Therapeutics N.V.\nDr. Manuela Bader, Director IR & Communication\nEmail: IR@vivoryon.com\n\nLifeSci Advisors\nSandya von der Weid \nTel: +41 78 680 05 38 \nEmail: svonderweid@lifesciadvisors.com\n\nAttachment\n* 2026-04-23_VVY_FY2025\n(https://ml-eu.globenewswire.com/Resource/Download/65b8f532-e685-48a9-a6c7-c7517508aeaa)"},"type":"article","timestamp":"2026-04-23T05:00:01.544847176Z","server_sent_at_ms":1776920401544},"received_at":"2026-04-23T05:00:01.598Z","source_url":null},"analysis":null,"durationMs":null,"modelName":null}}