Vivoryon Therapeutics N.V. Shares Highlights from Virtual R&D Update with KOL Speakers

Vivoryon Therapeutics N.V. Shares Highlights from Virtual R&D Update with KOL Speakers

Halle (Saale) / Munich, Germany, February 19, 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 key takeaways from its virtual R&D update with KOL (Key Opinion Leader) speakers held February 18, 2025. The event contextualized key data and statistical rigor supporting varoglutamstat's beneficial effect on kidney function reported in two independent Phase 2 studies, provided an update on the Company's clinical development plan for varoglutamstat in diabetic kidney disease (DKD), outlined varoglutamstat's potential market positioning and provided further data on its new development compound, VY2149.

The event featured presentations from Tobias B. Huber, MD, Professor of Medicine, and Kevin Carroll, PhD, CEO, KJC Statistics, as well as from Vivoryon's management.

"As we progress varoglutamstat through the next steps of clinical development in kidney disease, we are extremely encouraged to have the support from key experts in the field like Tobias and Kevin, whose counsel is instrumental in designing our clinical studies with the maximum chance of success in effectively addressing the great medical need in kidney disease, especially in our initial target population of stage 3b/4 DKD," said Frank Weber, MD, CEO of Vivoryon. "With varoglutamstat, we are in the unique position of having substantial clinical evidence to support an entirely novel mechanism of action designed to overcome the persisting hurdles in the development of viable, safe and effective therapies to not only slow progression, but to stabilize or even improve kidney function."

Highlights from Prof. Huber's presentation include:

• Current standard of care only reduces risk of CKD progression by approx. 1/3, meaning a significant risk remains of disease progression or premature death in a growing and aging population
• To alleviate this burden for patients and healthcare providers, therapies are urgently needed that reduce or reverse risk of progression in CKD/DKD and rare kidney disorders
• Inhibition of QPCTL represents a potentially novel CKD target and varoglutamstat has reported a consistent efficacy signal and treatment effect in two independent Phase 2 studies in patients with diabetes at different timepoints, with both VIVIAD and VIVA-MIND showing a statistically significant improvement in eGFR over baseline
• A responder analysis confirmed that the consistent effect seen in both studies was not driven by a few outliners but that the majority of patients (> 70%) responded to treatment
• In an effort to further elucidate mechanistic details in underlying varoglutamstat activity on kidney function, human kidney organoids were created that will be tested in an in vitro system to investigate specific effects of varoglutamstat on renal tissue
  
  

Highlights from Dr. Carroll's presentation include:

• The meta-analysis of VIVIAD and VIVA-MIND was conducted to provide the best overall assessment of efficacy of varoglutamstat and to statistically validate the homogeneity of outcomes
• The meta-analysis shows consistent results of high effect size and strongly supports viability of moving into a Phase 2b study in patients with diabetes with a comparatively low patient number, based on rigorous statistical planning and robust results

Highlights from presentations held by Vivoryon's management include:

• Inflammation and fibrosis have long been known as key drivers of kidney disease, yet attempts to develop effective therapeutics selectively targeting key pathways have had limited success
• Inhibiting QPCTL, an enzyme that creates pro-inflammatory pE-versions of key inflammatory proteins, has the potential to halt the progressive course of kidney disease through its novel approach to tackle inflammation and fibrosis, making it a promising target
• Vivoryon has compiled robust evidence demonstrating inhibition of intracellular QPCTL decreases activity of pro-inflammatory cytokines and kidney fibrosis all the way from in vitro and in vivo data to human clinical results
• Varoglutamstat is uniquely positioned within the evolving kidney disease landscape through its one-of-a-kind combination of key characteristics: oral availability, novel MOA addressing key components of disease pathways, single agent activity and suitability for use in combination therapies, demonstrated beneficial long-term effect on eGFR, long-term safety data confirmed
• The initial target market for varoglutamstat in late-stage DKD represents an attractive patient opportunity with a potential for expansion to earlier stages of DKD / CKD as well as orphan diseases
• Future opportunities include new development compound VY2149 which has preclinically shown improved cellular uptake and pharmacokinetics
• Vivoryon plans to initiate a double-blind placebo-controlled Phase 2b study in patients with type 2 diabetes and CKD stages 3b and worse on top of standard of care
• In-line with focusing resources on advancing in kidney disease, Vivoryon has decided to discontinue investigation of varoglutamstat in Alzheimer's disease
• Overall, Vivoryon is poised to improve kidney health with varoglutamstat's novel mechanism of action and breakthrough clinical study results
  
  

A replay of the webcast of the virtual R&D update will be available via the Presentations & Webcastspage in the Investor Relations section on the Company's website at www.vivoryon.com.

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About Varoglutamstat
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. Initially advanced 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 Phase 2b VIVIAD study in early AD included the investigation of kidney function (measured using 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.

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: [e-mail]

LifeSci Advisors
Sandya von der Weid
Tel: [phone]
Email: [e-mail]

Media Contact
Trophic Communications
Valeria Fisher or Verena Schossmann
Tel: [phone]
Email: [e-mail]

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