Vivoryon Therapeutics N.V. Reports Q1 2023 Financial Results and
Highlights Operational Progress
Vivoryon Therapeutics
N.V. Reports Q1 2023 Financial Results and
Highlights Operational Progress
Halle (Saale) / Munich,
Germany, May
16, 2023 –
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 and corporate updates
for the first quarter of 2023, ending March 31, 2023.
“In the first quarter of 2023, we continued to
advance our lead program for Alzheimer’s disease, varoglutamstat,
through both the VIVIAD and VIVA-MIND studies and reported further
data demonstrating both strong tolerability and improvements in
pathological hallmarks, synaptic function and connectivity,
cognition, memory and attention in AD patients,” said
Dr. Ulrich Dauer, CEO of Vivoryon. “Amidst steady
clinical progress with varoglutamstat, we are also encouraged by
the recent activity and developments in the broader AD treatment
landscape, in particular the emerging clinical evidence validating
our approach of targeting neurotoxic N3pE-Abeta. We believe we are
well-positioned for varoglutamstat to provide an effective and
much-needed therapeutic option that alleviates issues with
administration for patients with this devastating disease. Vivoryon
has an exciting year ahead and we look forward to reporting
important safety updates later this year for our VIVA-MIND trial in
the U.S. and final data from our VIVIAD study in the first quarter
of next year.”
Q1 2023 and
Post-Period
Portfolio Highlights
Varoglutamstat Clinical
Program:
- VIVIAD
(NCT04498650) is a state-of-the-art Phase 2b study being conducted
in Europe and designed to evaluate the safety, tolerability, and
efficacy of varoglutamstat in 250 subjects with mild cognitive
impairment (MCI) and mild Alzheimer’s disease (AD).
- In March 2023, Vivoryon provided an
update on varoglutamstat clinical development for the treatment of
AD at the International Conference on Alzheimer’s and Parkinson’s
Diseases and related neurological disorders (AD/PD). As of the data
cut-off date of January 5, 2023, over 100 of the
259 participants randomized into the VIVIAD study had been
treated for at least 48 weeks. Varoglutamstat showed no on-target
toxicity and no clinical signs of brain swelling or hemorrhages
(ARIA), which are a limiting class side effect of Abeta antibodies
and has been well-tolerated in the study to date. Both the total
number of SAEs and the discontinuation rate were considerably lower
than the respective numbers at the 800 mg BID varoglutamstat dose
in Vivoryon’s completed Phase 2a SAPHIR study, while retaining a
similar level of target inhibition (around 90%) at the dosing in
both studies.
- Vivoryon remains on track to report
the final data readout from the VIVIAD study in the first quarter
of 2024.
- VIVA-MIND
(NCT03919162) is a complementary Phase 2 study for varoglutamstat
conducted in the U.S. which seeks to enroll 180 patients with early
AD into the Phase 2a adaptive dose finding portion and enroll a
further 234 patients in the Phase 2b portion of the study.
- In March 2023, Vivoryon announced
the study is ongoing and continuing to recruit patients at 18 sites
across the U.S. The study’s independent DSMB recently provided a
unanimous recommendation to continue the study without
modification. The Company anticipates a decision on final trial
size following the data readout of the VIVIAD study.
- Vivoryon expects the first cohort
to be fully randomized into the study within the second quarter of
this year and plans to provide the next update on the VIVA-MIND
study in the second half of 2023.
Corporate Development
Highlights:
- In May 2023, Vivoryon announced it
will hold its 2023 Annual General Meeting on Wednesday, June 21,
2023, 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/annual-general-meeting-2023/)
.
- In May 2023, Vivoryon announced
intended changes among the Non-Executive members of its Board of
Directors at the 2023 Annual General Meeting. Reflecting Vivoryon’s
continued progress towards becoming a late-stage clinical
development company and in line with its commitment to meeting
international best-practice standards for corporate governance and
diversity, the Company proposes the appointment of Kugan
Sathiyanandarajah and Professor Morten Asser Karsdal as new members
to Vivoryon’s Non-Executive Board of Directors. The proposed
appointments follow the decision of the two long-standing members
Dinnies Johannes von der Osten, PhD, and Jörg Neermann, PhD, to
step down at the upcoming Annual General Meeting.
Financial Results for Q1 of
2023
No revenues were generated in
the first quarter of 2023.
Research and development
expenses decreased by EUR 2.7 million to EUR 3.1 million
in the three months ended March 31, 2023, compared to EUR 5.8
million in the three months ended March 31, 2022. This decrease was
largely attributable to a reduction of EUR 1.6 million from lower
manufacturing cost due to the completion of study drug supply
projects with the remaining reduction due to lower clinical costs
from the further progress of the Phase 2b clinical trial
VIVIAD.
General and administrative
expenses were EUR 1.9 million in the three months ended
March 31, 2023, compared to EUR 0.8 million in the three months
ended March 31, 2022. The increase of EUR 1.1 million was largely
attributable to EUR 0.8 million higher expenses for share-based
payments.
Net loss for the three months
ended March 31, 2023, was EUR 5.1 million, compared to EUR 6.4
million for the three months ended March 31, 2022.
The Company held EUR 17.1 million in
cash and cash equivalents as of March 31, 2023,
compared to EUR 26.6 million as of December 31, 2022. In the three
months ended March 31, 2023, the Company entered into a
Euro term deposit of EUR 3.0 million resulting in the reallocation
of the funds to financial assets from cash and cash
equivalents.
Financial Guidance
Following the capital raise settled in October
2022, according to current planning and estimates, Vivoryon expects
that its existing cash and cash equivalents will be sufficient to
fund its research and development expenses as well the general and
administrative expenses and cash flows from investing and financing
activities at least through end of December 2023. This guidance
does not include exercise of share options issued in October 2022,
potential milestone payments from development partnerships,
potential payments from licensing agreements and/or additional
financing measures, as far as such payments have not yet been
recognized in revenues. The financial guidance takes into account
all costs to ensure sustainable study drug supply with
varoglutamstat for the VIVA-MIND U.S. study.
Additional information regarding other relevant
information is included in the financial statements as of December
31, 2022, which were part the Company’s Annual Report 2022.
###
About Vivoryon Therapeutics
N.V.Vivoryon is a clinical stage biotechnology company
focused on developing innovative small molecule-based medicines.
Driven by our passion for ground-breaking science and innovation,
we strive to change the lives of patients in need suffering from
severe diseases. We leverage our 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. Beyond our lead program,
varoglutamstat, which is in Phase 2 clinical development to treat
Alzheimer’s disease, we have established a solid pipeline of
orally available small molecule inhibitors for various indications
including cancer, inflammatory diseases and fibrosis.
www.vivoryon.com
Vivoryon Forward Looking
StatementsThis press release includes forward-looking
statements, including, without limitation, those regarding the
business strategy, management plans and objectives for future
operations of the 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. Actual results,
performance 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 ContactStern IRJulie SeidelTel: +1
212-698-8684Email: SternIR-Vivoryon@sternir.com
Media ContactTrophic CommunicationsValeria
FisherTel: +49 175 8041816Email: vivoryon@trophic.eu
Vivoryon Therapeut (EU:VVY)
Gráfico Histórico do Ativo
De Nov 2024 até Dez 2024
Vivoryon Therapeut (EU:VVY)
Gráfico Histórico do Ativo
De Dez 2023 até Dez 2024
