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

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-- Additional kidney function analyses strongly support Vivoryon's shift in
strategic focus to inflammatory and fibrotic diseases, and are a further
step towards securing Company's future

-- Varoglutamstat`s beneficial effect of improving kidney function, as
demonstrated by an increase of estimated glomerular filtration rate
(eGFR), confirmed by various sensitivity and subgroup analyses

-- A significant and dose dependent reduction of the pyroglutamated version
of CCL2 (pE-CCL2) in serum demonstrates effectiveness of varoglutamstat
in inhibiting systemic intracellular QPCT/L and strongly supports an
anti-inflammatory effect

-- Alzheimer's disease: No consistent effect on cognition could be shown in
a subgroup of VIVIAD participants with higher drug exposure; VIVA-MIND
topline results available end 2024 to inform next steps in AD
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Halle (Saale) / Munich, Germany, May 23, 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 first quarter of 2024, ending March 31, 2024, and provides a corporate update.

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.

Q1 2024 and Post-Period Updates

Strategic shift towards a focus on inflammatory and fibrotic diseases:

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-- 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.
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Varoglutamstat -- kidney disease:

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-- 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.
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Primary analysis of change of estimated glomerular filtration rate (eGFR, slope analysis including all measurement timepoints during treatment):

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

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* mL/min/1.73m(2) /year

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

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Cystatin C and

Cystatin C           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*

()             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 
------------------  -------  -------  ----------  ----------  -------  ------- 

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* Baseline Adjusted LSMean Estimates

Varoglutamstat -- early Alzheimer's disease (AD):

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-- 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.
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Early-Stage Pipeline

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-- 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, in particular
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.
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Corporate Development Updates

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-- 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
(https://www.vivoryon.com/2024-annual-general-meeting/).
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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.

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