Vivoryon Therapeutics N.V. Reports Full Year 2022 Financial Results
and Highlights Operational Progress
Vivoryon Therapeutics N.V. Reports Full
Year 2022 Financial Results and
Highlights Operational Progress
- Significantly advanced varoglutamstat EU and U.S. clinical
studies, VIVIAD and VIVA-MIND, providing promising initial safety
data
- Both VIVIAD and VIVA-MIND studies on track; final data from
VIVIAD expected in 1Q2024 and clinical update on VIVA-MIND expected
in 2H2023
- Bolstered financial position with two successful private
placements to support ongoing clinical development totaling EUR 36
million with option for up to additional EUR 15 million
- Management to host conference call today at 3:00 pm CEST (9:00
am EDT)
Halle (Saale) / Munich,
Germany, April
19, 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 for the twelve-month
period ended December 31, 2022, and provided an update on its
corporate progress. The report is available on the Company's
website
https://www.vivoryon.com/investors-news/financial-information/
“We continue to solidify our position as leaders
in developing novel treatments for Alzheimer’s disease by following
differentiating science to thoughtfully inform the design of our
clinical trials. Our progress in 2022 underlines our dedication as
we continued to advance both VIVIAD and VIVA-MIND, while optimizing
their design based on meaningful findings both from varoglutamstat
and the broader AD treatment landscape,” said Dr. Ulrich Dauer, CEO
of Vivoryon. “In parallel, we’ve strengthened our financial
position with two successful private placements, welcoming in new
investors while also receiving continued support from existing
investors. Our extended cash runway enables Vivoryon to continue
executing against our pipeline goals and we are incredibly pleased
with the progress we’ve already made in 2023. We are driven by our
passion for developing small molecule-based medicines with a focus
on alleviating disease burden in more ways than just addressing
symptoms, such as ease of administration. We look forward to
upcoming inflection points later this year for our VIVA-MIND trial
in the U.S. and early next year for the final data from our VIVIAD
study.”
2022 and Post-Period Portfolio
Highlights
Varoglutamstat Clinical
Program:
VIVIAD
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 June 2022, Vivoryon announced
that it had completed the parallel group, dose-finding part of its
VIVIAD study and that the independent Data Safety Monitoring Board
(DSMB) selected the highest dose investigated, 600 mg twice daily
(BID), as the final dose to be administered in the second part of
the study.
- At the Alzheimer’s Association
International Conference (AAIC) in San Diego (July 31 to August 4,
2022), Vivoryon presented detailed safety data from the VIVIAD
study showing that varoglutamstat was well-tolerated at 600 mg
BID.
- In November 2022, Vivoryon
announced enrollment was completed and the study was adapted to
enable longer average treatment duration of participants
(anticipated average treatment duration ~82 weeks).
- In March 2023, Vivoryon announced
an update on the clinical development of varoglutamstat, including
the VIVIAD trial, at the International Conference on Alzheimer’s
and Parkinson’s Diseases and related neurological disorders (AD/PD)
in Gothenburg, Sweden. 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, with a
low number of adverse events (AEs), serious adverse events (SAEs),
and treatment emergent adverse events (TEAEs) observed. 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
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 November 2022, Vivoryon
announced the study design had been adapted to enable all 180
patients to be treated for at least 72 weeks, allowing for the
opportunity to progress seamlessly to a potential Phase 3 study,
possibly including further patients beyond the currently planned
414.
- In March 2023, Vivoryon provided an
update on the VIVA-MIND study, which 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.
Preclinical Programs:
- At the AAIC (July 31 to August 4,
2022), Vivoryon presented preclinical data on the Company’s N3pE
amyloid-targeting molecules. The results underscore the unique
potential of Vivoryon’s N3pE amyloid-targeting therapeutic strategy
in both mono- and combination therapy settings in AD. The data
showed that a combination treatment of aducanumab and
varoglutamstat achieves additive effect on Abeta pathology,
indicating feasibility of dose reduction to improve safety of Abeta
antibody-based AD treatments. This demonstrates the potential
benefit of a combination therapy designed to simultaneously make
use of two different and independent molecular N3pE-related mode of
actions, small molecule based QPCT/L inhibition and
anti-N3pE-immunotherapy. Additional data from murine analog of
PBD-C06 highlight the differentiated safety profile vs. other
anti-Abeta antibodies at N3pE amyloid-lowering concentrations.
- In October 2022, Nature
Communications issued a joint publication of Vivoryon and
Fraunhofer IZI and Monash University, Melbourne, Australia, titled,
“Helical ultrastructure of the metalloprotease meprin α in complex
with a small molecule inhibitor.” The article outlined the
protein’s involvement in tissue homeostasis by influencing
inflammation, immunity and extracellular matrix remodeling.
Dysregulation of this protein family leads to many severe diseases,
many of which are addressed by Vivoryon’s pipeline, including acute
kidney injury, inflammatory disease, in addition to some cancers.
Deepening Vivoryon’s understanding of meprin α’s structure will
strongly support the Company’s research and development program for
selective and highly potent small molecule meprin inhibitors.
Corporate Development
Highlights
- In February 2022, Vivoryon and its
partner, Simcere Pharmaceutical Group Ltd (“Simcere”), announced
that China's Center for Drug Evaluation (CDE) of National Medical
Products Administration (NMPA) approved the Clinical Trial
Application (CTA) for varoglutamstat for the development in Greater
China by Simcere. Simcere is fully responsible for the further
development and marketing within Greater China region.
- In April 2022, Vivoryon announced
that it had successfully completed a private placement by way of
accelerated book building, raising gross proceeds of EUR 21
million. The Company placed 2,000,000 registered shares at an
offering price of EUR 10.50 per share. The new shares were admitted
to trading on Euronext Amsterdam on April 5, 2022.
- In June 2022, the Company expanded
and diversified its Non-Executive Board with the appointments of
Claudia Riedl, PhD and Samir Shah, MD.
- In September 2022, the Company
entered into a private placement of 2,054,796 registered shares at
an offering price of EUR 7.30 per share, resulting in gross
proceeds of EUR 15 million. In addition, the investors have the
option to purchase further shares which, if exercised in full,
could raise up to an additional EUR 15 million. The private
placement was supported by Vivoryon’s longstanding investor Claus
Christiansen and Kohlberg Kravis Roberts & Co. L.P. (“KKR”)
Dawn Aggregator L.P. (“Dawn Biopharma”), a platform controlled by
affiliates of KKR, a leading global investment firm, as new
investor to the Company. The private placement was closed in the
fourth quarter of 2022 and the funds will support the ongoing
clinical development of Vivoryon’s lead candidate
varoglutamstat.
Financial Results for the Full Year
2022
No revenues were generated in
2022. The Company generated license revenues of EUR 10.8 million in
2021 from a regional licensing partnership with Simcere for Greater
China (Mainland China, Hong Kong, Macao and Taiwan).
Research and development
expenses increased by EUR 2.8 million to EUR 20.2 million
in the year ended December 31, 2022, compared to EUR 17.5 million
in the year ended December 31, 2021. Third-party research and
development services increased by EUR 2.5 million mainly because of
EUR 1.5 million higher manufacturing costs following the Company’s
risk mitigation strategy in establishing a second source for study
drug supply and higher clinical costs of EUR 1.0 million
mainly due to the progress of the Phase 2b clinical trial VIVIAD.
Other expenses increased by EUR 0.1 million as a result of higher
traveling costs.
General and administrative
expenses were EUR 8.9 million in 2022, compared to EUR 4.5
million in 2021. The increase of EUR 4.4 million was largely
attributable to EUR 2.6 million in expensed capital raising costs,
including legal and consulting fees associated with strategic and
operational efforts. An additional EUR 1.7 million in costs was due
to higher expenses for share based payments.
Net loss for the twelve months
ended December 31, 2022, was EUR 28.2 million, compared to EUR 12.7
million for the twelve months ended December 31, 2021. The Company
held EUR 26.6 million in cash and cash
equivalents as of December 31, 2022, compared to
EUR 14.7 million as of December 31, 2021.
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 as 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.
Conference Call and Webcast
Vivoryon will host a conference call and webcast
today, April 19, 2023, at 3:00 pm CEST (9:00 am EDT). A
Q&A session will follow the presentation of the full year
results.
A live webcast and slides will be made available at:
www.vivoryon.com/investors-news/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/BI4258c63704394e8283359d44ef59a7ea
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:
www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/
Vivoryon Therapeutics N.V. Financial
StatementsStatement of Operations and
Comprehensive Loss for the Years Ended December 31, 2022 and
2021
in kEUR, except for share
data |
2022 |
2021 |
|
|
|
Revenue |
— |
10,764 |
Cost of Sales |
— |
(1,569) |
Gross profit |
— |
9,196 |
Research and development expenses |
(20,224) |
(17,452) |
General and administrative expenses |
(8,908) |
(4,549) |
Other operating income |
19 |
7 |
Operating loss |
(29,113) |
(12,798) |
Finance income |
1,710 |
967 |
Finance expense |
(952) |
(392) |
Finance result |
758 |
575 |
Result before income taxes |
(28,355) |
(12,223) |
Income taxes |
199 |
(432) |
Net loss for the period |
(28,156) |
(12,655) |
Items not to be reclassified subsequently to profit or
loss |
|
|
Remeasurement of the net defined benefit pension liability |
392 |
83 |
Total other comprehensive income / (loss) |
392 |
83 |
Comprehensive loss |
(27,764) |
(12,572) |
Loss per share in EUR (basic and diluted) |
(1.28) |
(0.63) |
|
|
|
The accompanying notes are an integral part of
these financial statements.
Vivoryon Therapeutics N.V.Statements of
Financial Position as of December
31, 2022 and 2021
in
kEUR |
2022 |
2021 |
ASSETS |
|
|
Non-current assets |
|
|
Property, plant
and equipment |
49 |
66 |
Intangible
assets |
494 |
533 |
Right-of-use
assets |
127 |
219 |
Financial
assets |
14 |
3,473 |
Total
non-current assets |
684 |
4,291 |
Current
assets |
|
|
Financial
assets |
3,716 |
3,074 |
Other current
assets and prepayments |
423 |
2,494 |
Cash and cash
equivalents |
26,555 |
14,661 |
Total
current assets |
30,694 |
20,229 |
TOTAL
ASSETS |
31,378 |
24,520 |
|
|
|
Equity |
|
|
Share capital |
24,105 |
20,050 |
Share premium |
113,382 |
83,211 |
Other capital
reserves |
9,656 |
6,168 |
Accumulated other
comprehensive loss |
(180) |
(572) |
Accumulated
deficit |
(120,457) |
(92,300) |
Total
equity |
26,506 |
16,557 |
Non-current liabilities |
|
|
Pension
liability |
1,323 |
1,823 |
Provisions
long-term |
12 |
12 |
Lease
liabilities |
38 |
132 |
Other
liabilities |
— |
513 |
Deferred tax
liabilities |
234 |
432 |
Total
non-current liabilities |
1,607 |
2,912 |
Current
liabilities |
|
|
Provisions |
— |
35 |
Trade
payables |
2,543 |
4,360 |
Lease
liabilities |
94 |
92 |
Other
liabilities |
628 |
564 |
Total
current liabilities |
3,265 |
5,051 |
Total liabilities |
4,872 |
7,963 |
TOTAL
EQUITY AND LIABILITIES |
31,378 |
24,520 |
|
|
|
Vivoryon Therapeutics N.V.Statements of
Changes in Shareholders’ Equity for the Years Ended December
31, 2022 and 2021
in kEUR |
Share capital |
Share premium |
Other capital reserves |
Accumulated other compre-hensive loss |
Accumulated deficit |
Total equity |
January 1, 2021 |
19,975 |
82,143 |
4,404 |
(655) |
(79,646) |
26,221 |
Net loss for the period |
— |
— |
— |
— |
(12,655) |
(12,655) |
Remeasurement of the net defined benefit pension liability |
— |
— |
— |
83 |
— |
83 |
Comprehensive income / (loss) |
— |
— |
— |
83 |
(12,655) |
(12,572) |
Share-based payments |
— |
— |
1,763 |
— |
— |
1,763 |
Proceeds from exercise of share options |
75 |
1,069 |
— |
— |
— |
1,144 |
December 31, 2021 |
20,050 |
83,211 |
6,168 |
(572) |
(92,300) |
16,557 |
Net loss for the period |
— |
— |
— |
— |
(28,156) |
(28,156) |
Remeasurement of the net defined benefit pension liability |
— |
— |
— |
392 |
— |
392 |
Comprehensive income / (loss) |
— |
— |
— |
392 |
(28,156) |
(27,764) |
Proceeds from the issuance of common shares |
4,055 |
31,945 |
— |
— |
— |
36,000 |
Transaction costs of equity transactions |
— |
(1,774) |
— |
— |
— |
(1,774) |
Share-based payments |
— |
— |
3,488 |
— |
— |
3,488 |
December 31, 2022 |
24,105 |
113,382 |
9,656 |
(180) |
(120,457) |
26,506 |
|
|
|
|
|
|
|
Vivoryon Therapeutics N.V. Statements
of Cash Flows for the Years ended December 31,
2022 and 2021
in kEUR |
2022 |
2021 |
Operating activities |
|
|
Net loss for the period |
(28,156) |
(12,655) |
Adjustments for: |
|
|
Finance result |
(758) |
(575) |
Depreciation and amortization |
161 |
165 |
Share based payments |
3,488 |
1,763 |
Capitalized capital raising costs that were expensed |
2,633 |
— |
Actuarial gains / (losses) from pension liabilities |
392 |
83 |
Foreign currency gain (loss) from other items than cash |
373 |
287 |
Deferred income tax |
(199) |
432 |
Other non-cash adjustments |
61 |
(192) |
Changing in |
|
|
Financial assets |
2,817 |
(6,522) |
Other current assets and prepayments |
191 |
1,852 |
Pension liabilities |
(500) |
(158) |
Provisions |
(35) |
— |
Trade payables |
(1,817) |
3,449 |
Other liabilities |
(449) |
800 |
Interest received |
9 |
21 |
Interest paid |
(5) |
(7) |
Taxes paid |
— |
— |
Cash flows used in operating activities |
(21,794) |
(11,257) |
Investing activities |
|
|
Purchase of plant and equipment |
(11) |
(20) |
Purchase of intangible assets |
(2) |
(8) |
Cash flows used in investing activities |
(13) |
(28) |
Financing activities |
|
|
Proceeds from the issuance of common shares |
36,000 |
— |
Transaction costs of equity transactions |
(1,774) |
— |
Capital raising costs |
(753) |
(1,881) |
Payment of lease liabilities |
(92) |
(90) |
Proceeds from exercise of share options |
— |
1,144 |
Cash flows provided by /(used in) financing
activities |
33,381 |
(827) |
Net decrease in cash and cash equivalents |
11,574 |
(12,112) |
Cash and cash equivalents at the beginning of period |
14,661 |
26,306 |
Effect of exchange rate fluctuation on cash held |
320 |
467 |
Cash and cash equivalents at the end of
period |
26,555 |
14,661 |
|
|
|
Annual Financial Report 2022
The financial statements of Vivoryon have been
prepared in accordance with International Financial Reporting
Standards (IFRS) of the International Accounting Standards Board,
as adopted by the European Union (EU-IFRS) and with Section
2:362(9) of the Netherlands Civil Code. The auditor KPMG has issued
an unqualified auditor’s report for both statements. The reports
are available on the Company’s website www.vivoryon.com.
###
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)
Graphique Historique de l'Action
De Mar 2024 à Avr 2024
Vivoryon Therapeut (EU:VVY)
Graphique Historique de l'Action
De Avr 2023 à Avr 2024