Halle (Saale) / Munich, Germany, April 29, 2025 – Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on the discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, today announced financial results for the twelve-month period ended December 31, 2024, and provided an update on its corporate progress. The report is available on the Company's website https://www.vivoryon.com/investors-news/financial-information/.
“2024 has been a transformative year for Vivoryon, as we have successfully navigated the strategic shift into kidney disease, with a viable commercial strategy and solid IP in place, including the recent notice of allowance for a new varoglutamstat composition of matter patent in the U.S.,” said Frank Weber, MD, CEO of Vivoryon. “Backed by the robust body of clinical evidence we have built to date, we have designed an efficient, lean and focused Phase 2b study in DKD that is ideally suited to evaluate varoglutamstat in the intended target population of stage 3b and worse, and to maximize probability of success in kidney disease. We are confident that the expansion of our management team as well as our recently announced SEPA agreement offering additional financial flexibility are important steps in securing the future of the Company as we strive to fully realize the potential of our pre-clinical and clinical pipeline.”
Financial Year 2024 and Post-Period Pipeline Updates
Strategic shift towards a focus on inflammatory and fibrotic diseases, in particular on kidney disease
Varoglutamstat (PQ912) is a proprietary, potent and selective inhibitor of human glutaminyl cyclases QPCT and QPCTL with therapeutic potential in indications including inflammatory and fibrotic diseases, neurodegenerative diseases, cancer and others. Following the announcement on March 4, 2024, that the VIVIAD Phase 2b study did not achieve its primary and key secondary endpoints in early AD and the subsequent results showing a significant positive effect of varoglutamstat on kidney function, Vivoryon announced on April 24, 2024, a strategic shift towards a focus on inflammatory and fibrotic diseases.
Initially advancing development aiming to treat Alzheimer’s disease (AD), varoglutamstat has been investigated in a number of different clinical studies. Based on the known anti-inflammatory and anti-fibrotic activity of varoglutamstat, the protocol for the VIVIAD study included the investigation of kidney function (measured using estimated glomerular filtration rate, eGFR) and measurement of biomarkers of kidney inflammation and fibrosis to explore the role of QPCT/L inhibition on kidney function. eGFR was also analyzed as a prospectively defined safety parameter in the VIVA-MIND Phase 2 study in the U.S.
Varoglutamstat clinical program
Mechanism of action:
VIVIAD Phase 2b results of varoglutamstat on kidney function:
VIVA-MIND Phase 2 data confirm results of varoglutamstat’s benefit on eGFR in VIVIAD:
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 600mg twice daily significantly improved eGFR kidney function in the overall study population. The meta-analysis also confirmed a substantially larger effect size in study participants with diabetes compared to those without diabetes.
All Patients:
Stratification in Patients with Diabetes and without Diabetes:
Meta-analysis data from VIVIAD and VIVA-MIND was accepted for oral presentation at the 62nd European Renal Association (ERA) Congress 2025, to be held in Vienna, Austria, June 4-7, 2025.
Presentation details
Title: Varoglutamstat improves eGFR and offers a new approach to treat diabetic kidney disease (DKD): meta-analysis from two independent phase 2 studies.
Date/Time: June 6, 2025, 8:15 CEST
Presenter: Frank Weber, MD
Virtual R&D updates with key opinion leaders (KOLs) on kidney disease:
Vivoryon hosted two conference calls featuring expert presentations by seasoned KOLs.
Synergistic effect of combination treatment with varoglutamstat and SGLT2 inhibitors
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). The proposed study is expected to include approximately 90 subjects with stage 3b or worse DKD, randomized 1:1 to varoglutamstat 600mg orally twice daily or placebo, on top of standard of care medications. Intended endpoints include change of eGFR from baseline (primary endpoint), measures of albuminuria (UA(p)CR), inflammation, metabolic and fibrosis-related biomarkers, as well as safety. Initiation of all future studies is subject to additional funding and/or partnership, which Vivoryon will continue to actively explore.
Varoglutamstat in early Alzheimer’s disease (AD):
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 expected to enter formal, late-stage pre-clinical development within this year, subject to additional funding and/or partnership, which Vivoryon will continue to actively explore.
In addition, early-stage initiatives focus on:
Patent portfolio further strengthened
Vivoryon pursues a stringent strategy to continuously strengthen its IP around key assets. As of April 28, 2025, the Company has a strong patent portfolio of 22 patent families comprising over 400 national patent applications and issued patents, predominantly on composition of matter (COM) for QPCT/L inhibitors. In 2024 and 2025 year-to-date, the Company further strengthened its patent portfolio with regard to its frontrunner molecule varoglutamstat, follow-up programs and applications in kidney diseases. These activities included filing a new varoglutamstat COM patent application in the U.S., for which Vivoryon recently received a notice of allowance following the completion of an accelerated examination process. Expansion to rest of the world (ROW) is expected by the end of 2025. In addition, based on recent experimental data, a new combination patent application was filed for QPCT/L inhibitors (varoglutamstat and VY2149) in combination with SGLT2 inhibitors. Aiming to generate multiple layers of protection, the Company has also filed additional IP on medical use for varoglutamstat and backup compounds/VY2149, as well as on dosing regimens and on the use of varoglutamstat and related structures (e.g. VY2149) for the treatment of kidney diseases.
Financial Year 2024 and Post-Period Corporate Updates
Financial Results for the Full Year 2024
No Revenues were generated in 2024.
Research and development expenses decreased by EUR 3.6 million to EUR 14.1 million in the year ended December 31, 2024, compared to EUR 17.6 million in the year ended December 31, 2023. The decrease was primarily attributable to EUR 3.0 million lower third-party expenses, mainly because of EUR 1.9 million lower manufacturing cost and lower clinical costs of EUR 1.1 million largely due to the ramp-down of the VIVIAD Phase 2b clinical study.
General and administrative expenses were EUR 6.9 million in the year ended December 31, 2024, compared to EUR 8.6 million in the year ended December 31, 2023. The decrease of EUR 1.7 million was largely attributable to lower expenses for personnel (EUR 0.6 million), legal and consulting (EUR 0.5 million) and non-executive directors compensation (EUR 1.3 million), offset by higher provision (EUR 0.6 million). The reasons for the decrease in personnel costs and costs for non-executive Board members were predominantly caused by the decrease in share-option expenses (EUR 1.0 million). Furthermore, the Company has accrued a long-term provision for potential compensation payment in the amount of EUR 635 thousand for legal cases.
Net loss in the year ended December 31, 2024, was EUR 20.6 million, compared to EUR 28.3 million in the year ended December 31, 2023.
The Company held EUR 9.4 million in cash and cash equivalents as of December 31, 2024, compared to cash and cash equivalents of EUR 18.6 million plus term deposits of EUR 10.0 million disclosed under current financial assets as of December 31, 2023.
Cash flows used in operating activities were EUR 19.2 million in the year ended December 31, 2024, compared to EUR 21.5 million in the year ended December 31, 2023.
Cash flows provided by (-) / used in investing activities were EUR -10.0 million in the year ended December 31, 2024, compared to EUR 10.5 million in the year ended December 31, 2023. This difference was predominantly driven by changes in term deposits.
Cash flows provided from financing activities were EUR 0.1 million in the year ended December 31, 2024, compared to EUR 24.2 million in the year ended December 31, 2023.
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 the recently announced SEPA as well as other potential additional financing transactions, if any. This guidance is updated from the Company’s prior guidance of cash runway into the third quarter of 2025, as published on December 10, 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 financial statements have been prepared on the basis that the Company will continue as a going concern. The Company expects to have continuing operating losses for the foreseeable future and the need to raise additional capital to finance its future operations, and, as of April 29, 2025, the Company has concluded that the ability to continue as a going concern in the financial year 2026 depends on the ability to generate additional funding. 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, April 29, 2025, at 3:00 pm CEST (9:00 am EDT). A Q&A session will follow the presentation of the full 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/BI2bda60f4f9a245db834bc976d4d9ddd9
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
Statement of Operations and Comprehensive Loss for the Years Ended December 31, 2024 and 2023
| in kEUR, except for share data | 2024 | 2023 |
| Revenue | — | (3,620) |
| Cost of Sales | — | 525 |
| Gross profit | — | (3,095) |
| Research and development expenses | (14,058) | (17,637) |
| General and administrative expenses | (6,903) | (8,600) |
| Other operating income | — | 495 |
| Other operating expense | (3) | — |
| Operating loss | (20,964) | (28,837) |
| Finance income | 482 | 726 |
| Finance expense | (86) | (465) |
| Finance result | 396 | 261 |
| Result before income taxes | (20,568) | (28,576) |
| Income taxes | — | 234 |
| Net loss for the period | (20,568) | (28,342) |
| Items not to be reclassified subsequently to profit or loss | ||
| Remeasurement of the net defined benefit pension liability | (12) | (76) |
| Total other comprehensive (loss) / income | (12) | (76) |
| Comprehensive loss | (20,580) | (28,418) |
| Loss per share in EUR (basic and diluted) | (0.79) | (1.12) |
The accompanying notes are an integral part of these financial statements.
Vivoryon Therapeutics N.V.
Statements of Financial Position as December 31, 2024 and 2023
| in kEUR | 2024 | 2023 |
| ASSETS | ||
| Non-current assets | ||
| Property, plant and equipment | 24 | 40 |
| Intangible assets | 865 | 941 |
| Right-of-use assets | 100 | 36 |
| Other non-current assets | 228 | — |
| Total non-current assets | 1,217 | 1,017 |
| Current assets | ||
| Financial assets | 63 | 10,165 |
| Other current assets and prepayments | 639 | 1,085 |
| Cash and cash equivalents | 9,365 | 18,562 |
| Total current assets | 10,067 | 29,812 |
| TOTAL ASSETS | 11,284 | 30,829 |
| Equity | ||
| Share capital | 261 | 26,067 |
| Share premium | 161,477 | 135,671 |
| Other capital reserves | 15,777 | 13,599 |
| Accumulated other comprehensive loss | (268) | (256) |
| Accumulated deficit | (169,367) | (148,799) |
| Total equity | 7,880 | 26,282 |
| Non-current liabilities | ||
| Pension liability | 1,317 | 1,353 |
| Provisions long-term | 647 | 12 |
| Lease liabilities | 42 | — |
| Total non-current liabilities | 2,006 | 1,365 |
| Current liabilities | ||
| Trade payables | 1,015 | 2,894 |
| Lease liabilities | 60 | 38 |
| Other liabilities | 324 | 250 |
| Total current liabilities | 1,399 | 3,182 |
| Total Liabilities | 3,405 | 4,547 |
| TOTAL EQUITY AND LIABILITIES | 11,284 | 30,829 |
The accompanying notes are an integral part of these financial statements.
Vivoryon Therapeutics N.V.
Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2024 and 2023
| in kEUR | Share capital | Share premium | Other capital reserves | Accumulated other comprehen-sive loss | Accumulated deficit | Total equity | |
| January 1, 2023 | 24,105 | 113,382 | 9,656 | (180) | (120,457) | 26,506 | |
| Net loss for the period | — | — | — | — | (28,342) | (28,342) | |
| Remeasurement of the net defined benefit pension liability | — | — | — | (76) | — | (76) | |
| Comprehensive (loss) / income | — | — | — | (76) | (28,342) | (28,418) | |
| Proceeds from the issuance of common shares | 1,786 | 23,214 | — | — | — | 25,000 | |
| Transaction costs of equity transactions | — | (2,095) | — | — | — | (2,095) | |
| Share-based payments | — | — | 3,943 | — | — | 3,943 | |
| Proceeds from exercise of share options | 176 | 1,170 | — | — | — | 1,346 | |
| December 31, 2023 | 26,067 | 135,671 | 13,599 | (256) | (148,799) | 26,282 | |
| Net loss for the period | — | — | — | — | (20,568) | (20,568) | |
| Remeasurement of the net defined benefit pension liability | — | — | — | (12) | — | (12) | |
| Comprehensive (loss) / income | — | — | — | (12) | (20,568) | (20,580) | |
| Proceeds from the issuance of common shares | — | — | — | — | — | — | |
| Transaction costs of equity transactions | — | — | — | — | — | — | |
| Capital (decrease) / increase | (25,806) | 25,806 | — | — | — | — | |
| Share-based payments | — | — | 2,178 | — | — | 2,178 | |
| Proceeds from exercise of share options | — | — | — | — | — | — | |
| December 31, 2024 | 261 | 161,477 | 15,777 | (268) | (169,367) | 7,880 | |
The accompanying notes are an integral part of these financial statements.
Vivoryon Therapeutics N.V.
Statements of Cash Flows for the Years ended December 31, 2024 and 2023
| in kEUR | 2024 | 2023 |
| Operating activities | ||
| Net loss for the period | (20,568) | (28,342) |
| Adjustments for: | ||
| Finance result | (396) | (261) |
| Depreciation and amortization | 147 | 167 |
| Share based payments | 2,178 | 3,943 |
| Deferred income tax | — | (234) |
| Reversal of Revenue and Accounts Receivable | — | 3,095 |
| Provisions | 635 | — |
| Other non-cash adjustments | 4 | — |
| Changing in | ||
| Other current and non-current assets and prepayments | 218 | (662) |
| Pension liabilities | (94) | (94) |
| Trade payables | (1,899) | 538 |
| Other liabilities | 76 | (17) |
| Interest received | 526 | 328 |
| Interest paid | (1) | (2) |
| Cash flows used in operating activities | (19,174) | (21,541) |
| Investing activities | ||
| Purchase of plant and equipment | (2) | (14) |
| Purchase of intangible assets | — | (500) |
| Purchase of financial assets | — | (19,000) |
| Proceeds from sale of financial assets | 10,000 | 9,000 |
| Cash flows used in investing activities | 9,998 | (10,514) |
| Financing activities | ||
| Proceeds from the issuance of common shares | — | 25,000 |
| Transaction costs of equity transactions | — | (2,095) |
| Payment of lease liabilities | (57) | (94) |
| Proceeds from exercise of share options | — | 1,346 |
| Cash flows provided by / (used in) financing activities | (57) | 24,157 |
| Net decrease in cash and cash equivalents | (9,233) | (7,898) |
| Cash and cash equivalents at the beginning of period | 18,562 | 26,555 |
| Effect of exchange rate fluctuation on cash held | 36 | (95) |
| Cash and cash equivalents at the end of period | 9,365 | 18,562 |
The accompanying notes are an integral part of these financial statements.
Annual Financial Report 2024
The financial statements of Vivoryon have been prepared in accordance with International Financial Reporting Standards (IFRS) of the International Accounting Standards Board, as adopted by the European Union (EU-IFRS) and with Section 2:362(9) of the Netherlands Civil Code. The auditor KPMG has issued an unqualified auditor's report for both statements. The reports are available on the Company’s website www.vivoryon.com.
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About Vivoryon Therapeutics N.V.
Vivoryon is a clinical stage biotechnology company focused on developing innovative small molecule-based medicines. Driven by its passion for ground-breaking science and innovation, the Company strives to change the lives of patients in need suffering from severe diseases. The Company leverages its in-depth expertise in understanding post-translational modifications to develop medicines that modulate the activity and stability of proteins which are altered in disease settings. The Company has established a pipeline of orally available small molecule inhibitors for various indications including Alzheimer’s disease, inflammatory and fibrotic disorders, including of the kidney, and cancer. 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 Contacts
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
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