Vivoryon Therapeutics N.V. Reports H1 2024 Progress Marked by Compelling Kidney Function Data and Execution of Strategy to Advance Varoglutamstat in Kidney Disease
Vivoryon Therapeutics reported significant advancements in H1 2024, particularly with varoglutamstat, a Phase 2 drug showing notable improvements in kidney function for patients with kidney disease. The VIVIAD Phase 2b study highlighted a statistically significant benefit in eGFR and reduced pro-inflammatory cytokine pE-CCL2 levels. A significant benefit was also noted in diabetic subgroups, leading to plans for a Phase 2 study in diabetic kidney disease (DKD).
The company shifted focus to inflammatory and fibrotic diseases due to these results. Financially, Vivoryon reported a net loss of €13.6M for H1 2024 and a decrease in cash and equivalents to €15.3M.
Key upcoming events include a conference call and a virtual Kidney Disease KOL webcast to discuss the drug's potential further. The company is also seeking business development and financing opportunities to support its initiatives.
Vivoryon Therapeutics ha riportato significativi progressi nel primo semestre del 2024, in particolare con varoglutamstat, un farmaco in fase 2 che mostra notevoli miglioramenti nella funzione renale per pazienti con malattia renale. Lo studio VIVIAD di fase 2b ha evidenziato un beneficio statisticamente significativo nell'eGFR e una riduzione dei livelli del citochina pro-infiammatoria pE-CCL2. Un beneficio significativo è stato osservato anche nei sottogruppi diabetici, portando a piani per uno studio di fase 2 sulla malattia renale diabetica (DKD).
L'azienda ha spostato l'attenzione verso le malattie infiammatorie e fibrotiche a causa di questi risultati. Dal punto di vista finanziario, Vivoryon ha riportato una perdita netta di 13,6 milioni di euro per il primo semestre del 2024 e una diminuzione della liquidità e equivalenti a 15,3 milioni di euro.
Tra i principali eventi in programma ci sono una conference call e un webcast virtuale con esperti sulla malattia renale per discutere ulteriormente del potenziale del farmaco. L'azienda sta inoltre cercando opportunità di sviluppo commerciale e finanziamento per supportare le sue iniziative.
Vivoryon Therapeutics informó sobre avances significativos en el primer semestre de 2024, especialmente con varoglutamstat, un medicamento en fase 2 que muestra mejoras notables en la función renal para pacientes con enfermedad renal. El estudio VIVIAD en fase 2b destacó un beneficio estadísticamente significativo en el eGFR y niveles reducidos de la citoquina pro-inflamatoria pE-CCL2. También se observó un beneficio significativo en subgrupos diabéticos, lo que llevó a planes para un estudio de fase 2 en enfermedad renal diabética (DKD).
La compañía cambió su enfoque hacia las enfermedades inflamatorias y fibrosas debido a estos resultados. Desde el punto de vista financiero, Vivoryon reportó una pérdida neta de 13,6 millones de euros para el primer semestre de 2024 y una disminución en efectivo y equivalentes a 15,3 millones de euros.
Los eventos clave que se avecinan incluyen una llamada de conferencia y un webcast virtual sobre la enfermedad renal con expertos para discutir más sobre el potencial del medicamento. La empresa también está buscando oportunidades de desarrollo comercial y financiamiento para apoyar sus iniciativas.
Vivoryon Therapeutics는 2024년 상반기에 주목할 만한 성과를 보고하였으며, 특히 varoglutamstat라는 2상 약물이 신장 질환 환자의 신장 기능에서 눈에 띄는 개선을 보였습니다. VIVIAD 2b상 연구는 eGFR에서 통계적으로 유의미한 이점과 pro-inflammatory cytokine pE-CCL2 수치의 감소를 강조했습니다. 또한 당뇨병 하위 그룹에서도 유의미한 이점이 관찰되어 당뇨병 신장 질환(DKD)과 관련된 2상 연구 계획으로 이어졌습니다.
회사는 이러한 결과로 인해 염증 및 섬유질 질환으로 초점을 옮겼습니다. 재무적으로, Vivoryon은 2024년 상반기에 1360만 유로의 순손실을 기록했으며, 현금 및 현금성 자산은 1530만 유로로 감소했습니다.
주요 향후 행사에는 약물의 잠재력을 논의하기 위한 컨퍼런스 콜과 가상 신장 질환 KOL 웨비나가 포함됩니다. 또한 이 회사는 자사 이니셔티브를 지원하기 위해 비즈니스 개발 및 자금 조달 기회를 모색하고 있습니다.
Vivoryon Therapeutics a rapporté des avancées significatives au premier semestre 2024, en particulier avec varoglutamstat, un médicament de phase 2 montrant des améliorations notables dans la fonction rénale des patients atteints de maladies rénales. L'étude VIVIAD de phase 2b a mis en évidence un bénéfice statistiquement significatif dans l'eGFR et des niveaux réduits de la cytokine pro-inflammatoire pE-CCL2. Un bénéfice significatif a également été observé chez les sous-groupes diabétiques, ce qui a conduit à des plans pour une étude de phase 2 dans la maladie rénale diabétique (DKD).
L'entreprise a déplacé son attention vers les maladies inflammatoires et fibrotiques en raison de ces résultats. Sur le plan financier, Vivoryon a enregistré une perte nette de 13,6 millions d'euros pour le premier semestre 2024 et une diminution de sa trésorerie et équivalents à 15,3 millions d'euros.
Les événements clés à venir comprennent une conférence téléphonique et un webcast virtuel sur la maladie rénale pour discuter davantage du potentiel du médicament. L'entreprise recherche également des opportunités de développement commercial et de financement pour soutenir ses initiatives.
Vivoryon Therapeutics berichtete über bedeutende Fortschritte im ersten Halbjahr 2024, insbesondere mit varoglutamstat, einem Medikament in Phase 2, das bemerkenswerte Verbesserungen der Nierenfunktion bei Patienten mit Nierenerkrankungen zeigt. Die VIVIAD-Studie der Phase 2b hob einen statistisch signifikanten Vorteil bei eGFR und reduzierte Werte des pro-inflammatorischen Zytokins pE-CCL2 hervor. Auch in diabetischen Untergruppen wurde ein signifikanter Vorteil festgestellt, was zu Plänen für eine Phase-2-Studie zur diabetischen Nierenerkrankung (DKD) führte.
Aufgrund dieser Ergebnisse verlagerte das Unternehmen den Fokus auf entzündliche und fibrotische Erkrankungen. Finanzielle Ergebnisse zeigen, dass Vivoryon für das erste Halbjahr 2024 einen Nettverlust von 13,6 Millionen Euro und einen Rückgang der liquiden Mittel auf 15,3 Millionen Euro berichtete.
Wichtige bevorstehende Ereignisse umfassen eine Telefonkonferenz und ein virtuelles Webinar zur Nierenerkrankung, um das Potenzial des Medikaments weiter zu diskutieren. Das Unternehmen sucht auch nach Geschäftsentwicklungs- und Finanzierungsmöglichkeiten zur Unterstützung seiner Initiativen.
- Significant improvement in kidney function (eGFR) in VIVIAD Phase 2b study.
- Notable benefit in diabetic subgroups (>8mL/min/1.73m2/year).
- Plans for a Phase 2 study in diabetic kidney disease (DKD).
- Clear strategic shift towards inflammatory and fibrotic diseases due to compelling data.
- Reduction in pro-inflammatory cytokine pE-CCL2 levels.
- Varoglutamstat well-tolerated with no significant adverse events.
- Net loss of €13.6M for H1 2024.
- Decrease in cash and equivalents to €15.3M from €28.6M.
- R&D expenses increased by €4.0M to €10.3M.
- No revenues reported for H1 2024.
Insights
The VIVIAD Phase 2b study results for varoglutamstat in kidney function are highly promising. The statistically significant improvement in eGFR of 3.4mL/min/1.73m2/year (p<0.001) in the overall population and >8mL/min/1.73m2/year (p=0.02) in the diabetes subgroup are clinically meaningful. These effects, coupled with the reduction in pro-inflammatory cytokine pE-CCL2, suggest strong potential in treating diabetic kidney disease (DKD).
The planned Phase 2 study in DKD targeting more advanced disease stages (3b/4) is a strategic move to address a significant unmet medical need. The focus on eGFR slope, albuminuria and inflammatory biomarkers as endpoints aligns well with regulatory expectations for kidney disease trials.
However, the failure to meet primary and secondary endpoints in Alzheimer's disease is a setback. The company's pivot to kidney disease appears justified based on the data, but it represents a major shift in therapeutic focus that will require careful execution.
Vivoryon's financial position is concerning. With cash and cash equivalents of
The increased R&D expenses (
The strategic shift towards kidney disease, while promising, introduces execution risks and potential delays in revenue generation. Vivoryon will need to carefully manage its resources and potentially seek dilutive financing to fund the planned Phase 2 DKD study, which could impact shareholder value in the near term.
Vivoryon's pivot from Alzheimer's disease to kidney disorders, particularly DKD, is a bold but necessary move. The QPCT/L inhibition mechanism of varoglutamstat shows promise in addressing inflammatory and fibrotic processes, which are key in kidney disease progression.
The company's focus on both large indications like DKD and rare diseases such as Fabry and Alport Syndrome demonstrates a strategic approach to market opportunities. This diversification could enhance the asset's value proposition for potential partners or acquirers.
However, the competitive landscape in kidney disease is intensifying, with several large pharma companies and biotechs developing novel therapies. Vivoryon will need to move quickly and efficiently to establish a strong position. The planned KOL event in September is a positive step in building credibility in this new therapeutic area.
Overall, while the shift introduces new risks, it also opens up significant potential if varoglutamstat can demonstrate robust efficacy in upcoming kidney disease trials.
Vivoryon Therapeutics N.V. Reports H1 2024 Progress Marked by Compelling Kidney Function Data and Execution of Strategy to Advance Varoglutamstat in Kidney Disease
- Primary focus is developing varoglutamstat, a Phase 2 investigational medicine with potential to improve kidney function in patients with kidney disease
- Statistically significant benefit of varoglutamstat on prospectively defined key kidney function endpoint (eGFR1) and significant reduction of pro-inflammatory cytokine pE-CCL2 observed in VIVIAD Phase 2b AD study
- Substantially higher treatment benefit of varoglutamstat on eGFR observed in post-hoc diabetes subgroup2 triggering plans to advance varoglutamstat into Phase 2 study in DKD3
- Gained further insight into AD results through clear evidence of differences between kidney and AD outcomes from PK/PD analysis and new target occupancy information
- Management to host a conference call today at 3:00pm CEST (9:00am EDT)
- Vivoryon to host a virtual Kidney Disease KOL (Key Opinion Leaders) webcast on Monday, September 30 at 3:00 pm CEST (9:00 am EDT) to elaborate on varoglutamstat’s potential in kidney disease with an emphasis on DKD
Halle (Saale) / Munich, Germany, September 12, 2024 - 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 six-month period ended June 30, 2024, and provides a corporate update. The report is available on the Company’s website https://www.vivoryon.com/financial-information/.
“The VIVIAD Phase 2b study showed outstanding results in improving kidney function and we made strong progress during the first half of 2024 in forging a new development strategy for varoglutamstat in diabetic kidney disease (DKD),” said Frank Weber, MD, CEO of Vivoryon. “In parallel, we advanced pharmacokinetic and biomarker analyses which demonstrate a strong dose response of varoglutamstat on kidney function improvement. Furthermore, as we continue the evolution of our understanding of the Alzheimer’s disease (AD) VIVIAD results, we have generated the first evidence that varoglutamstat activity is required in the cells of the brain – not only in the cerebrospinal fluid - to stop the pathological process of pE-Abeta production.” He concluded, “The VIVIAD data demonstrate varoglutamstat has an excellent safety and tolerability profile, provide strong support for our understanding of the potential of QPCTL inhibitors in inflammatory and fibrotic diseases and lay the foundation for our strategic shift towards kidney disease based on the outstanding effect we observed on eGFR.”
H1 2024 and Post-Period Updates
Strategic shift towards a focus on inflammatory and fibrotic diseases
A significant positive effect of varoglutamstat on kidney function observed in the VIVIAD Phase 2b study in AD underpins the strategic shift to inflammatory and fibrotic diseases. In April 2024, Vivoryon announced this strategic shift following the announcement in March 2024 that the VIVIAD Phase 2b study did not achieve its primary and key secondary endpoints in early AD.
The VIVIAD protocol prospectively specified measurement of kidney function by estimated glomerular filtration rate (eGFR), a primary endpoint in many development programs of kidney disorders, and additional biomarkers, in order to further investigate this potential activity.
Key priorities now include:
- Preparing for a proposed Phase 2 clinical study for varoglutamstat in diabetic kidney disease (subject to additional funding and/or partnership);
- Concluding VIVIAD Phase 2b clinical study program and in-depth analysis;
- Analyzing the data of the VIVA-MIND Phase 2 clinical study with varoglutamstat in the U.S. in early AD by year end 2024;
- Continuing to actively pursue potential business development and financing opportunities.
Varoglutamstat Mechanism of Action
- Post-translational modification occurs both physiologically and in disease settings and it is a crucial process to functionalize proteins. Many different post-translational modifications are catalyzed by enzymes that have become known drug targets, e.g. kinases, proteases, or methylases.
- Pyroglutamate (pE) formation, a specific post-translational modification catalyzed by the glutaminyl cyclase enzymes QPCT and QPCTL, has emerged as a central element in different diseases including neurodegenerative, inflammatory and fibrotic diseases as well as cancer.
- Varoglutamstat is a highly potent oral small molecule inhibitor of human QPCT and QPCTL, designed to prevent inflammatory and fibrotic processes by blocking pyroglutamate formation on key disease drivers.
- QPCTL inhibition has demonstrated robust evidence of efficacy in animal models of inflammatory and fibrotic disorders such as glomerulonephritis and non-alcoholic steatohepatitis (NASH).
Varoglutamstat – VIVIAD kidney function results (total study population)
- Varoglutamstat 600mg BID increased eGFR over the treatment period up to 96 weeks in patients with early AD, indicating a potential benefit of varoglutamstat on kidney function. The treatment effect in the overall VIVIAD study population was 3.4mL/min/1.73m2/year (p<0.001; varoglutamstat n=141 / placebo n=117).
- Further sensitivity and subgroup analysis has shown this effect is observed across the range of eGFR levels at baseline in the study, and when assessed using a set of diverse and validated methods for calculating kidney function.
- Additionally, the Company has explored the effect of varoglutamstat on levels of pyroglu-CCL2 (pE-CCL2), a pro-inflammatory cytokine. Persistent, low grade inflammation is considered a hallmark feature of chronic kidney disease (CKD). Results showed a significant and dose-dependent reduction in pE-CCL2 in the serum of VIVIAD patients following treatment with varoglutamstat. This demonstrates the effectiveness of varoglutamstat in inhibiting systemic intracellular QPCTL and strongly supports an anti-inflammatory effect.
Significant effects of varoglutamstat in diabetes subgroup2
- Analysis of eGFR in a subgroup of patients with diabetes2 in the VIVIAD Phase 2b study reveals a substantially higher treatment effect4 of >8mL/min/1.73m2/year (p=0.02; varoglutamstat n=20 / placebo n=12) compared to the overall VIVIAD study population where the treatment effect was 3.4mL/min/1.73m2/year (p<0.001; varoglutamstat n=141 / placebo n=117).
- Promising additional effects were observed in the diabetes subgroup in varoglutamstat treated patients including a reduction in liver transaminases, mild weight loss, and a reduction in diastolic blood pressure.
- Data revealed that the positive effect on kidney function in the diabetes subgroup appears to be independent of any change in glycemic control (HbA1C remained steady over the period for the varoglutamstat group).
- A reduction of the plasma concentration of the inflammatory and fibrosis inducing pE-CCL2 (p=0.004) was observed in the varoglutamstat arm, indicating a strong anti-inflammatory effect.
- Varoglutamstat was well-tolerated at the dose tested (up to 600mg twice daily) and there were no meaningful differences in adverse events observed in renal and metabolic system organ classes versus placebo or the total population.
Proposed Clinical Development Plan in Diabetic Kidney Disease (DKD)3
- Despite advances in the standard of care for DKD, there remains a significant unmet need for new therapies to stabilize kidney function and prevent disease progression.
- Vivoryon plans to start a Phase 2 study in DKD that is intended to include patients with disease stages more advanced than those observed in the VIVIAD Phase 2 study, enabling an expansion of the overall target patient population. The Company envisages a placebo-controlled study of up to approximately 120 subjects with stage 3b/4 DKD. These subjects would be randomized 1:1 to varoglutamstat 600mg twice daily or placebo, on top of standard of care medications. Key endpoints are planned to include eGFR slope analysis, measures of albuminuria (UA(p)CR), inflammation and fibrosis-related biomarkers, as well as safety.
- Vivoryon is evaluating business development and financing opportunities, to further explore the potential of varoglutamstat and QPCT/L inhibitors in kidney disease in both large indications, such as DKD, and in certain rare diseases that impact kidney function, such as Fabry disease and Alport Syndrome.
Varoglutamstat – early Alzheimer’s disease (AD)
- Vivoryon has continued its in-depth analysis of the VIVIAD data. Findings to date continue to confirm there is no consistent effect of varoglutamstat up to 600mg BID on cognition and function, including in high exposure patients. Results from pharmacokinetic, pharmacodynamic and biomarker data, including an assay for measuring pE-Abeta forms, suggests that intracellular QPCT may play a greater role in driving clinical outcomes in AD. Data from VIVA-MIND, anticipated by the end of 2024, is expected to contribute to the overall dataset informing varoglutamstat’s development strategy in AD.
Corporate Development Updates
- In March 2024, Kugan Sathiyanandarajah and Professor Dr. Morten Asser Karsdal stepped down from Vivoryon’s Board of Directors. They had been appointed as Non-Executive Directors in June 2023.
- In March 2024, Anne Doering, CFA, assumed the role of Chief Financial Officer (CFO) of Vivoryon, following her previous position as Chief Strategy & Investor Relations Officer.
- Vivoryon held its 2024 Annual General Meeting (AGM) on Friday, June 21, 2024, at 1:00 p.m. (CEST) 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/2024-annual-general-meeting/). Agenda items of particular note include the reappointment of Dr. Michael Schaeffer, Chief Business Officer, as executive director as well as the amendment to the Company’s articles of association with regard to, among other changes, the decrease of the nominal value of the shares in the capital of the Company to EUR 0.01 from EUR 1.00, which was implemented on September 5, 2024.
Financial Results for the First Half of 2024
Revenues were zero in the six months ended June 30, 2024, as well as in the six months ended June 30, 2023.
Research and development expenses increased by EUR 4.0 million to EUR 10.3 million in the six months ended June 30, 2024, compared to EUR 6.3 million in the six months ended June 30, 2023. This increase was largely attributable to the increase in clinical development costs from the VIVIAD and VIVA-MIND studies as well as early investments into kidney related research.
General and administrative expenses were EUR 3.5 million in the six months ended June 30, 2024, compared to EUR 4.4 million in the six months ended June 30, 2023. The decrease of EUR 0.9 million was largely attributable to higher non-executive board compensation in 2023.
Net loss for the six months ended June 30, 2024, was EUR 13.6 million, compared to EUR 10.7 million for the six months ended June 30, 2023.
The Company held EUR 15.3 million in cash and cash equivalents as of June 30, 2024, compared to EUR 28.6 million, which includes cash and cash equivalents and term deposits within financial assets, as of December 31, 2023. Cash utilization for the first six months of 2024 reflects the intensive investment period in VIVIAD and VIVA-MIND, both of which are expected to meaningfully ramp down in the second half 2024 as both studies approach their conclusion.
Outlook & Financial Guidance
As published on April 24, 2024, the Company expects, on the basis of its most recent financial and business plan, that its existing cash and cash equivalents will be sufficient to fund its operating plans, excluding any additional financings, into the second quarter of 2025.
This cash runway guidance reflects the shift in focus of research and development resources towards inflammatory and fibrotic disorders, such as of the kidney, and an overall reduction in cash utilization including the ramp down of spending on VIVIAD as it approaches its conclusion, the discontinuation of VIVA-MIND, the discontinuation of VIVALONG preparation activities given the developments of VIVIAD and VIVA-MIND, as well as the streamlining of manufacturing costs and programs for API development.
The viability of the Company beyond the second quarter of 2025 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.
Conference Call and Webcast
Vivoryon will host a conference call and webcast today, September 12, 2024, at 3:00 pm CEST (9:00 am EDT). A Q&A session will follow the presentation of the first half 2024 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.vevent.com/register/BIb82f5f65fffe4d5faaade135258da32a
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/
Virtual Kidney Disease Key Opinion Leaders Event on September 30, 2024
Vivoryon will host a virtual Kidney Disease KOL (Key Opinion Leaders) conference call and webcast on Monday, September 30, 2024, featuring expert presentations by seasoned KOLs followed by a Q&A session on the standard of care and existing medical need, market development and commercial potential in kidney disorders, as well as evidence generation and statistical principles in kidney disease drug development, with special emphasis on diabetic kidney disease.
Featured speakers:
- Tobias B. Huber, MD - Chair of the Center of Internal Medicine and Director of the III. Department of Medicine - University Medical Center Hamburg-Eppendorf (UKE), Germany. Acting as Medical Advisor for clinical study design. Research collaboration with Vivoryon focusing on pre-clinical and mechanistic activities relating to varoglutamstat and the role of QPCT/L on kidney function.
- Florian Jehle - CEO of Vifor-FMC Renal Pharma. Acting as Industry Expert Advisor to Vivoryon in the kidney field including strategic business and commercial advice.
- Kevin Carroll, PhD - CEO, KJC Statistics. Acting as statistical analysis expert, providing and calculating statistical read-outs and advising on clinical study statistical aspects.
Conference call details
Date: September 30, 2024
Time: 3:00 pm CEST / 9:00 am EDT
A live webcast and slides will be made available at: https://www.vivoryon.com/news-and-events/presentations-webcasts/
Please register to join the conference call via the following website:
https://edge.media-server.com/mmc/p/b8g57xvh/
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Vivoryon Therapeutics N.V. Financial Statements
Unaudited Statement of Operations and Comprehensive Loss for the Six Months Ended June 30, 2024 and 2023
| For the six months ended June 30, | ||
| in kEUR, except for share data | 2024 (unaudited) | 2023 (unaudited) |
| Research and development expenses | (10,308) | (6,259) |
| General and administrative expenses | (3,501) | (4,433) |
| Operating loss | (13,809) | (10,692) |
| Finance income | 303 | 258 |
| Finance expenses | (53) | (327) |
| Finance result | 250 | (69) |
| Result before income taxes | (13,559) | (10,761) |
| Income taxes | — | 45 |
| Net loss for the period | (13,559) | (10,716) |
| Items not to be reclassified subsequently to profit or loss | ||
| Remeasurement of the net defined benefit pension liability | 39 | (9) |
| Total other comprehensive profit / (loss) | 39 | (9) |
| Comprehensive loss | (13,520) | (10,725) |
| Loss per share in EUR (basic and diluted) | (0.52) | (0.44) |
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, 2024 and December 31, 2023 (audited)
| in kEUR | June 30, 2024 (unaudited) | December 31, 2023 (audited) |
| ASSETS | ||
| Non-current assets | ||
| Property, plant and equipment | 31 | 40 |
| Intangible assets | 904 | 941 |
| Right-of-use assets | 9 | 36 |
| Total non-current assets | 944 | 1,017 |
| Current assets | ||
| Financial assets | 74 | 10,165 |
| Other current assets and prepayments | 701 | 1,085 |
| Cash and cash equivalents | 15,272 | 18,562 |
| Total current assets | 16,047 | 29,812 |
| TOTAL ASSETS | 16,991 | 30,829 |
| Equity | ||
| Share capital | 26,067 | 26,067 |
| Share premium | 135,671 | 135,671 |
| Other capital reserves | 14,817 | 13,599 |
| Accumulated other comprehensive loss | (217) | (256) |
| Accumulated deficit | (162,358) | (148,799) |
| Total equity | 13,980 | 26,282 |
| Non-current liabilities | ||
| Pension liability | 1,287 | 1,353 |
| Provisions long-term | 12 | 12 |
| Total non-current liabilities | 1,299 | 1,365 |
| Current liabilities | ||
| Trade payables | 1,465 | 2,894 |
| Lease liabilities | 10 | 38 |
| Other liabilities | 237 | 250 |
| Total current liabilities | 1,712 | 3,182 |
| Total Liabilities | 3,011 | 4,547 |
| TOTAL EQUITY AND LIABILITIES | 16,991 | 30,829 |
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, 2024 and 2023
| in kEUR | Share capital | Share premium | Other capital reserves | Accumulated other comprehensive loss | Accumulated deficit | Total equity |
| January 1, 2024 | 26,067 | 135,671 | 13,599 | (256) | (148,799) | 26,282 |
| Net loss for the period | — | — | — | — | (13,559) | (13,559) |
| Remeasurement of the net defined benefit pension liability | — | — | — | 39 | — | 39 |
| Comprehensive loss | — | — | — | 39 | (13,559) | (13,520) |
| Proceeds from the issuance of common shares | — | — | — | — | — | — |
| Transaction costs of equity transactions | — | — | — | — | — | — |
| Share-based payments | — | — | 1,218 | — | — | 1,218 |
| Exercise of share options | — | — | — | — | — | — |
| June 30, 2024 | 26,067 | 135,671 | 14,817 | (217) | (162,358) | 13,980 |
| January 1, 2023 | 24,105 | 113,382 | 9,656 | (180) | (120,457) | 26,506 |
| Net loss for the period | — | — | — | — | (10,716) | (10,716) |
| Remeasurement of the net defined benefit pension liability | — | — | — | (9) | — | (9) |
| Comprehensive loss | — | — | — | (9) | (10,716) | (10,725) |
| Proceeds from the issuance of common shares | 1,786 | 23,214 | — | — | — | 25,000 |
| Transactions costs of equity transactions | — | (2,095) | — | — | — | (2,095) |
| Exercise of share options | — | — | 2,305 | — | — | 2,305 |
| Share-based payments | 71 | 472 | — | — | — | 542 |
| June 30, 2023 | 25,962 | 134,973 | 11,961 | (189) | (131,173) | 41,534 |
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, 2024 and 2023
| For the six months ended June 30, | ||
| in kEUR | 2024 (unaudited) | 2023 (unaudited) |
| Operating activities | ||
| Net loss for the period | (13,559) | (10,716) |
| Adjustments for: | ||
| Finance result | (250) | 69 |
| Depreciation and amortization | 73 | 79 |
| Share based payments | 1,218 | 2,305 |
| Foreign currency gain (loss) from other items than cash | (25) | (59) |
| Deferred income tax | — | (45) |
| Other non-cash adjustments | 19 | (33) |
| Changing in: | ||
| Financial assets | (4) | (8,938) |
| Other current assets and prepayments | 383 | (2,036) |
| Pension liabilities | (66) | (13) |
| Trade payables | (1,429) | (1,252) |
| Other liabilities | (13) | 306 |
| Interest received | 353 | 51 |
| Interest paid | — | (1) |
| Cash flows used in operating activities | (13,300) | (20,283) |
| Investing activities | ||
| Purchase of plant and equipment | — | (9) |
| Proceeds from sale of financial assets | 10,000 | — |
| Cash flows used in investing activities | 10,000 | (9) |
| Financing activities | ||
| Proceeds from the issuance of common shares | — | 25,000 |
| Capital raising costs | — | (2,095) |
| Proceeds from exercise of share options | — | 542 |
| Payment of lease liabilities | (28) | (47) |
| Cash flows provided by financing activities | (28) | 23,400 |
| Net increase in cash and cash equivalents | (3,328) | 3,109 |
| Cash and cash equivalents at the beginning of period | 18,562 | 26,555 |
| Effect of exchange rate fluctuation on cash held | 38 | (82) |
| Cash and cash equivalents at end of period | 15,272 | 29,582 |
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. 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 Contact
Vivoryon Therapeutics N.V.
Dr. Manuela Bader, Director IR & Communication
Tel: +49 (0)345 555 99 30
Email: IR@vivoryon.com
Media Contact
Trophic Communications
Valeria Fisher
Tel: +49 175 8041816
Email: vivoryon@trophic.eu
1Estimated glomerular filtration rate (eGFR), a validated measure of kidney function, was calculated as a slope analysis across two years taking all available data into account.
2Diabetes subgroup defined as patients having at baseline either medical history of diabetes (type 1 or 2) and/or comedication with drugs used in diabetes and/or untreated with an HbA1c >
3The timing and execution of the planned Phase 2 study is subject to additional funding / partnership.
4Treatment effect – the between-group difference in eGFR slope between varoglutamstat and placebo.
Attachment
FAQ
What progress did Vivoryon Therapeutics report in H1 2024?
What were the financial results of Vivoryon Therapeutics for H1 2024?
What is the significance of varoglutamstat in kidney disease according to Vivoryon's H1 2024 report?
What upcoming events did Vivoryon announce in its H1 2024 report?
What strategic shift did Vivoryon Therapeutics announce in H1 2024?
What are Vivoryon's plans for varoglutamstat in diabetic kidney disease (DKD)?
