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## Vivoryon Therapeutics N.V. Reports Q1 2024 Financial Results and New Data Reinforcing Strategic Focus in Kidney Disease

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 first quarter of 2024, ending March 31, 2024, and provides a corporate update.

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“Vivoryon has now achieved proof of concept for varoglutamstat and validated the mechanism of action of QPCT/L inhibition. While the results in early AD were not what we had hoped for, we are excited about the promising effect of varoglutamstat on the pre-specified endpoint of kidney function given the established role of pro-inflammatory cytokines and peptides in driving the progression of kidney disease. In the past weeks, our team, which remains highly dedicated to driving our strategic shift and transformation, has continued to delve into the data on kidney function and we are pleased to see consistent results. We have observed robust and meaningful improvements in eGFR in patients treated with varoglutamstat compared to placebo across a range of different methods assessing eGFR. Effect sizes in favor of varoglutamstat were confirmed in patients with risk factors for CKD including diabetes and hypertension and were observed consistently across the range of eGFR baseline impairment levels in the study. We are now working on crystallizing our strategy and positioning in the kidney disease market and establishing potential clinical development plans for varoglutamstat in both large indications, such as CKD, and in certain rare diseases that impact kidney function,” said Frank Weber, MD, CEO of Vivoryon.

### Strategic Shift towards a Focus on Inflammatory and Fibrotic Diseases

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. Key priorities now include: exploring varoglutamstat’s potential in inflammatory and fibrotic disorders, including of the kidney; concluding VIVIAD Phase 2b clinical study program and in-depth analysis; discontinuing VIVA-MIND clinical Phase 2 study with varoglutamstat in the U.S. in early AD in the second half of 2024; leveraging the data from VIVA-MIND to inform next steps in AD; and continuing to actively pursue potential business development and financing opportunities.

### Varoglutamstat – Kidney Disease

QPCT/L inhibition has shown robust evidence of benefits in animal models of inflammatory and fibrotic disorders such as glomerulonephritis and non-alcoholic steatohepatitis (NASH). 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.

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.

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 QPCT/L and strongly supports an anti-inflammatory effect.

Vivoryon is evaluating a clinical development path, as well as 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 CKD, and in certain rare diseases that impact kidney function, such as Alport Syndrome.

### Primary Analysis of Change of Estimated Glomerular Filtration Rate (eGFR)

| | Annualized change of eGFR* | P-Value | Annualized Change of eGFR* | P-Value |
|——————-|—————————|———|—————————|———|
| Formula (creatinine) | MDRD | | CKD-EPI 2021 | |
| Placebo | -1.51 | | -0.75 | |
| Varoglutamstat | +1.92 | | +1.44 | |
| Treatment Effect (Δ) | 3.43 | p=0.0002 | 2.19 | p=0.0015 |

* mL/min/1.73m2/year

Sensitivity analysis of estimated glomerular filtration (eGFR) rate using Cystatin C and Creatinine (remeasured on Atellica® platform) CKD-EPI 2021 formula at baseline, week 24, and week 48:

| | Cystatin C | | Cystatin C and Creatinine | | Creatinine | |
|————————|————|————-|—————————-|————-|————|————-|
| | Week 24 | Week 48 | Week 24 | Week 48 | Week 24 | Week 48 |
| Placebo (eGFR mL/min) | 73.88 | 71.39 | 84.15 | 82.07 | 89.74 | 88.74 |
| Varoglutamstat (eGFR mL/min) | 78.15 | 80.88 | 88.91 | 91.21 | 93.33 | 93.98 |
| Treatment Effect* (Δ) | 4.27 | 9.49 | 4.76 | 9.14 | 3.59 | 5.24 |
| P-Value | 0.0186 | <0.0001 | 0.0041 | <0.0001 | 0.0019 | 0.0003 | * Baseline Adjusted LSMean Estimates ### Varoglutamstat – Early Alzheimer's Disease (AD) In recent weeks, Vivoryon has continued its in-depth analysis of the VIVIAD data, following the March 4, 2024, and April 24, 2024, disclosures. While these analyses remain ongoing, 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. 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. ### Early-Stage Pipeline Vivoryon’s main focus is on its clinical-stage activities, however, it will continue to explore pre-clinical QPCT/L inhibitors for use in inflammatory and fibrotic disorders and other indications such as oncology and CNS as well as pre-clinical meprin inhibitors, particularly for fibrotic disorders, and QPCT/L inhibitors with good blood-brain barrier penetration. The Company’s antibody program, PBD-C06, will remain active as a candidate for further potential partnering opportunities. ### 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. In May 2024, Vivoryon announced it will hold its 2024 Annual General Meeting on Friday, June 21, 2024, at 1:00 p.m. (CEST) in Amsterdam, the Netherlands. The full agenda and all relevant documents are available on the Company’s website. ### Financial Results for the First Quarter of 2024 - **Revenues:** were zero in the three months ended March 31, 2024, as well as in the three months ended March 31, 2023. - **Research and Development Expenses:** increased by EUR 4.3 million to EUR 7.4 million in the three months ended March 31, 2024, compared to EUR 3.1 million in the three months ended March 31, 2023. - **General and Administrative Expenses:** were EUR 2.1 million in the three months ended March 31, 2024, compared to EUR 1.9 million in the three months ended March 31, 2023. - **Net Loss:** for the three months ended March 31, 2024, was EUR 9.3 million, compared to EUR 5.1 million for the three months ended March 31, 2023. - The Company held EUR 22.0 million in **cash and cash equivalents** as of March 31, 2024, compared to EUR 28.6 million as of December 31, 2023. ### 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 the 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 focusing on exploring opportunities in kidney disease. ### Conference Call and Webcast Vivoryon will host a conference call and webcast on May 23, 2024, at 3:00 pm CEST (9:00 am EDT). A live webcast and slides will be available for participants to dial into the conference call via the provided link. ### About Vivoryon Therapeutics N.V. Vivoryon is a clinical-stage biotechnology company focused on developing innovative small molecule-based medicines. The Company leverages its expertise in understanding post-translational modifications to develop medicines that modulate the activity and stability of proteins altered in disease settings. ### Vivoryon Forward Looking Statements This press release includes forward-looking statements regarding the business strategy, management plans, and objectives for future operations of Vivoryon Therapeutics N.V. Words such as “anticipate,” “believe,” “estimate,” and more are intended to identify such forward-looking statements. The Company's results and financial effects may differ from expectations. This press release does not contain risk factors, and certain risk factors that may affect the Company’s future financial results are discussed in its published annual financial statements. 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: [email protected] Media Contact Trophic Communications Valeria Fisher Tel: +49 175 8041816 Email: [email protected]
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