Vivoryon Therapeutics N.V. Reports Full Year 2023 Financial Results and Provides
Varoglutamstat and Strategic Updates
* In-depth analysis of VIVIAD Phase 2b results is ongoing, including pre-
specified and exploratory endpoints; findings to date are consistent with
previously announced topline data observing no statistically significant or
clinically meaningful effect of varoglutamstat on cognition and function in
early AD up to 600mg twice a day (BID) dose
* Statistically significant improvement in kidney function observed with
varoglutamstat 600mg BID in VIVIAD over two years based on pre-specified
analysis of the estimated glomerular filtration rate
* Company plans to explore potential of varoglutamstat in kidney disease in a
shift of strategic focus towards inflammatory and fibrotic disorders
* VIVA-MIND Phase 2 study to be discontinued early, in H2 2024, which will
enable accelerated data analysis and inform varoglutamstat development
strategy
* Company is taking steps to reduce cash utilization and will prioritize
resources on exploring varoglutamstat in kidney disease, VIVIAD and VIVA-
MIND data analysis, select pipeline programs, and continuing business
development
* Based on current financial and business plans, including the discontinuation
of VIVA-MIND, Company's cash runway is now expected to extend into Q2 2025
without additional financing
* Management to host conference call today at 3:00pm CEST (9:00am EDT)
Halle (Saale) / Munich, Germany, April 24, 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 twelve-month period ended December 31, 2023, and
provided varoglutamstat and strategic updates including its pipeline development
priorities and financial guidance.
"2023 was a year of clinical progress as we prepared for the readout from our
VIVIAD Phase 2b study and advanced our U.S. study, VIVA-MIND, in early
Alzheimer's disease. We were very disappointed to report negative results from
VIVIAD in March of this year, given the significant unmet need for new disease-
modifying therapies. Our ongoing analysis of the topline data confirms that
there was no consistent effect of varoglutamstat on cognition and function at
the 600mg dose and we are continuing our in-depth analysis to uncover key
learnings and inform our long-term strategy in AD. Varoglutamstat's safety
profile continues to look encouraging and we are excited to report today that we
have observed a statistically significant improvement in kidney function based
on pre-specified analysis of the estimated glomerular filtration rate measured
in VIVIAD. This is in line with our prior hypothesis and results of
pharmacological research on the role of the QPCT/L pathway beyond AD and is a
very promising development. We are now prioritizing our resources and research
and development activities to maximize value from varoglutamstat and our
pipeline, with a focus on exploring its potential role in inflammatory and
fibrotic diseases, including kidney disease, and determining additionally
whether a path forward is viable in AD," said Frank Weber, M.D., CEO of
Vivoryon.
He continued, "Based on the VIVIAD analysis, and an assessment of funding needs,
we have taken the decision, jointly with our principal investigator, to
discontinue the VIVA-MIND study in early AD in the second half of 2024. This
will enable us to accelerate analysis of patients treated in the study and
explore varoglutamstat's effect on certain endpoints including EEG theta power
and kidney function and look for any trends in cognition. We hope the data from
VIVA-MIND will increase our understanding of the role of QPCT/L inhibition in AD
and evolve the science behind this devastating disease."
In light of recent developments, the Company is today announcing prioritization
of its resources into research and development activities it believes have the
greatest potential to provide a meaningful impact for patients and for value
creation. Key priorities reflect the strategic shift towards a focus on
inflammatory and fibrotic diseases and include:
* Exploring varoglutamstat's potential in inflammatory and fibrotic disorders,
including of the kidney,
* Concluding VIVIAD Phase 2b clinical study program for varoglutamstat in
Europe, including an in-depth analysis of the results presented on March
4, 2024, and further ongoing biomarker analysis,
* Discontinuing VIVA-MIND clinical Phase 2 study with varoglutamstat in the
U.S. in the second half of 2024, earlier than planned, enabling accelerated
analysis of the results which will contribute to the overall dataset
informing varoglutamstat's development strategy moving forward,
* Assessing the potential of varoglutamstat in doses higher than 600mg BID
orally in early Alzheimer's disease,
* Continuing to actively pursue potential business development and financing
opportunities.
2023 and Post-Period Updates
Varoglutamstat Clinical Program:
VIVIAD study in early AD
VIVIAD (NCT04498650) is a state-of-the-art Phase 2b study conducted in Europe
and designed to evaluate the safety, tolerability, and efficacy of
varoglutamstat in 259 subjects with mild cognitive impairment (MCI) and mild
Alzheimer's disease (AD).
* In March 2024, Vivoryon announced topline data for VIVIAD. The study, which
evaluated varoglutamstat up to 600mg BID, did not meet its primary endpoint
of a statistically significant difference in cognitive improvement over
time, assessed by the combined Z-score of the three elements of the Cogstate
3-item scale, as well as key secondary endpoints measuring cognition and
function including the Cogstate Brief Battery (CBB); complete Cogstate
neuropsychological test battery (NTB); the Amsterdam Instrumental Activities
of Daily Living Questionnaire (A-IADL-Q) and electroencephalogram (EEG)
global theta power.
* Safety results from the study showed that varoglutamstat was generally well
tolerated and showed rates similar to placebo of serious and severe
treatment emergent adverse events (TEAEs), low discontinuation rates due to
adverse events and no evidence of symptomatic ARIAs (amyloid-related imaging
abnormalities) in the clinical setting.
* Vivoryon is conducting an in-depth analysis of the VIVIAD data. While these
analyses remain ongoing, findings to date confirm the topline results.
Additionally, no statistically significant or clinically meaningful effect
of varoglutamstat up to 600mg BID was observed on pre-specified subgroups.
The only significant difference observed in favor of varoglutamstat was a
lower change from baseline in the WAIS IV coding test and the letter fluency
test, both measuring cognitive dysfunction, at week 48. Pharmacokinetic and
QPCT/L enzyme inhibition data in VIVIAD were consistent with previous
results.
VIVIAD study - results from kidney function exploratory analyses
* The VIVIAD protocol prospectively specified measurement of certain kidney
function biomarkers. This was in line with the Company's previously
announced growth strategy to explore varoglutamstat's potential effects on
kidney function.
* Varoglutamstat 600mg BID increased the estimated glomerular filtration rate
(eGFR) over the treatment period up to 96 weeks, indicating a potential
benefit of varoglutamstat on kidney function. Analysis is ongoing including
a closer analysis of VIVIAD results in patients with different eGFR levels
at baseline.
* Given these statistically significant and clinically meaningful data,
Vivoryon is evaluating a development path including business development and
financing opportunities to further explore the potential of varoglutamstat
and QPCT/L inhibitors in kidney disease.
VIVA-MIND study in early AD
VIVA-MIND (NCT03919162) is a Phase 2 study conducted in the U.S. evaluating the
safety, tolerability, and efficacy of varoglutamstat in patients with early AD.
* Vivoryon announced today that, based on the ongoing review of VIVIAD data
published March 4, 2024, and an assessment of funding needs, the Company has
decided jointly with its principal investigator, to voluntarily discontinue
the Phase 2 VIVA-MIND study in early AD in the U.S. in the second half of
2024. This will enable accelerated analysis of the results and will
contribute to the overall dataset informing varoglutamstat's development
strategy moving forward. Initial data from the study is anticipated by the
end of 2024.
* In October 2023, Vivoryon announced the study's independent data and safety
monitoring board (DSMB) recommended to continue VIVA-MIND with a 600mg BID
dose throughout Phase 2a and 2b, which is an accelerated up-titration
protocol compared to the VIVIAD Phase 2b study. This decision followed
safety reviews and analyses of treatment-emergent adverse events of special
interest (AESI) occurring in skin and subcutaneous tissue disorders and
hepatobiliary disorders, target occupancy and pharmacokinetic (PK) data.
VIVALONG study
VIVALONG is an open-label extension (OLE) study offering a long-term treatment
option to patients after completing VIVIAD or VIVA-MIND protocols.
* In line with the Company's cost reduction measures and given the
developments of VIVIAD and VIVA-MIND, Vivoryon has decided to stop VIVALONG
OLE study preparation activities.
Early-Stage Pipeline
Vivoryon is revisiting the early-stage opportunities in its R&D activities in
line with its strategic shift.
* Future pre-clinical activities will involve exploring QPCT/L inhibitors for
use in inflammatory and fibrotic disorders as well as in other indications
such as oncology and CNS.
* Opportunities with meprin inhibitors will continue to be explored, in
particular for fibrotic disorders.
* The Company's antibody program, PBD-C06, will remain active as a candidate
for further potential partnering opportunities.
* The Company will continue to explore identification of second generation
QPCT/L inhibitors with good blood brain barrier penetration.
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
previously 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 October 2023, Vivoryon hosted a virtual R&D Event with Key Opinion
Leaders (KOLs), focusing on varoglutamstat.
* In September 2023, Vivoryon held an Extraordinary General Meeting (EGM)
related to the appointment of Frank Weber, MD, as CEO and Executive member
of the Board of Directors. He followed Dr. Ulrich Dauer, former CEO of
Vivoryon, after Dr. Dauer's announcement in June 2023 to not renew his
contract with the Company.
* In August 2023, Vivoryon and Scenic Biotech B.V. ("Scenic") reached an
agreement regarding the settlement of their patent dispute in connection
with certain of Vivoryon´s patents related to varoglutamstat (PQ912) and
certain other QPCT inhibitors. As part of the settlement, Scenic's
affiliate, Scenic Immunology B.V., and Vivoryon have entered into a patent
license agreement, under which Scenic Immunology B.V. granted to Vivoryon
certain rights to certain patents controlled by Scenic Immunology B.V. in
the field of oncology.
* In May 2023, Vivoryon successfully raised EUR 25 million through an
accelerated bookbuild offering. The private placement totaled 1,785,715
ordinary shares, at an issue price of EUR 14.00 per share.
Financial Results for the Full Year 2023
Revenues for the year ended December 31, 2023, reflected a EUR 3.6 million
reversal in license revenue, compared to no revenue in the year ended December
31, 2022. The reversal is related to license revenues recognized in 2021 from a
strategic regional licensing partnership with Simcere Pharmaceutical Group Ltd.
("Simcere") to treat Alzheimer's disease (AD) in Greater China, which includes a
variable compensation for the first milestone. This variable milestone payment
of EUR 3.6 million is based on the initiation of the first human clinical trial
of varoglutamstat in mainland China. After the end of the reporting period the
anticipated first milestone revenues were re-assessed. Due to the VIVIAD Phase
2b study not meeting its primary and key secondary endpoints, it is expected
that the first human clinical trial in mainland China will not start before
further clarity from an in-depth analysis of the VIVIAD results as well as from
additional analysis of the full data and its implications. Therefore, revenues
for the variable compensation (first development milestone) are no longer highly
probable. As a consequence, the milestone-receivable of EUR 3.6 million was
impaired and the respected revenues were reversed, as of December 31, 2023.
Research and development expenses decreased by EUR 2.6 million to EUR 17.6
million in the year ended December 31, 2023, compared to EUR 20.2 million in the
year ended December 31, 2022. The decrease is primarily attributable to EUR 2.7
million lower third-party expenses, mainly due to EUR 3.6 million lower
manufacturing costs, partially offset by EUR 1.7 million higher clinical costs,
mainly due to the progress of the Phase 2b VIVIAD clinical study.
General and administrative expenses were EUR 8.6 million in the year ended
December 31, 2023, compared to EUR 8.9 million in the year ended December
31, 2022. The decrease of EUR 0.3 million is largely attributable to the release
of EUR 2.6 million of previously capitalized capital raising costs in 2022,
partially offset by EUR 2.2 million higher expenses for personnel, legal and
consulting, as well as costs for Non-Executive Directors. The reasons for the
cost increases in personnel and for the Non-Executive Directors of the Board
were predominantly caused by accelerated share-option expenses (EUR 0.3 million)
and severance payments (EUR 0.6 million) as a result of the 2023 Board changes.
Net loss in the year ended December 31, 2023, was EUR 28.3 million, compared to
EUR 28.2 million in the year ended December 31, 2022.
The Company held EUR 18.6 million in cash and cash equivalents as of December
31, 2023, plus term deposits of EUR 10.0 million disclosed under current
financial assets, compared to cash and cash equivalents of EUR 26.6 million as
of December 31, 2022.
Cash flows used in operating activities were EUR 21.5 million in the year ended
December 31, 2023, compared to EUR 21.8 million in the year ended December
31, 2022.
Cash flows used in investing activities were EUR 10.5 million in the year ended
December 31, 2023, compared to EUR 13 thousand in the year ended December
31, 2022. This difference reflects the net purchase of term deposits in the
amount of EUR 10.0 million during 2023.
Cash flows provided from financing activities were EUR 24.2 million in the year
ended December 31, 2023, compared to EUR 33.4 million in the year ended December
31, 2022.
Outlook & Financial Guidance
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 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. These
activities also represent a change in focus of research and development
resources towards inflammatory and fibrotic disorders, such as of the kidney,
from an emphasis on Alzheimer's disease.
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 such as those
focusing on exploring opportunities in kidney disease.
The financial statements have been prepared on the basis that the Company will
continue as a going concern. The Company expects to have continuing operating
losses for the foreseeable future and the need to raise additional capital to
finance its future operations, and, as of April 24, 2024, the Company has
concluded that the ability to continue as a going concern in the financial year
2025 depends on the ability to generate additional funding. Please refer to the
Company's Annual Report 2023 for further information.
Conference Call and Webcast
Vivoryon will host a conference call and webcast today, April 24, 2024, 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/ (http://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/BI3fef74de02dc40daa7cbe0aac7731e74
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/ (http://www.vivoryon.com/investors-news/news-and-
events/presentations-webcasts/)
###
Vivoryon Therapeutics N.V. Financial Statements
Statement of Operations and Comprehensive Loss for the Years Ended December
31, 2023 and 2022
in kEUR, except for share data 2023 2022
Revenue (3,620) -
Cost of Sales 525 -
------------------
Gross profit (3,095) -
------------------
Research and development expenses (17,637) (20,224)
General and administrative expenses (8,600) (8,908)
Other operating income 495 19
Other operating expense - -
Operating loss (28,837) (29,113)
Finance income 726 1,710
Finance expense (465) (952)
Finance result 261 758
Result before income taxes (28,576) (28,355)
Income taxes 234 199
Net loss for the period (28,342) (28,156)
Items not to be reclassified subsequently to profit or loss
Remeasurement of the net defined benefit pension liability (76) 392
Total other comprehensive (loss) / income (76) 392
Comprehensive loss (28,418) (27,764)
Loss per share in EUR (basic and diluted) (1.12) (1.28)
The accompanying notes are an integral part of these financial statements.
Vivoryon Therapeutics N.V.
Statements of Financial Position as December 31, 2023 and 2022
in kEUR 2023 2022
ASSETS
Non-current assets
Property, plant and equipment 40 49
Intangible assets 941 494
Right-of-use assets 36 127
Financial assets - 14
Total non-current assets 1,017 684
Current assets
Financial assets 10,165 3,716
Other current assets and prepayments 1,085 423
Cash and cash equivalents 18,562 26,555
Total current assets 29,812 30,694
TOTAL ASSETS 30,829 31,378
Equity
Share capital 26,067 24,105
Share premium 135,671 113,382
Other capital reserves 13,599 9,656
Accumulated other comprehensive loss (256) (180)
Accumulated deficit (148,799) (120,457)
Total equity 26,282 26,506
Non-current liabilities
Pension liability 1,353 1,323
Provisions long-term 12 12
Lease liabilities - 38
Deferred tax liabilities - 234
Total non-current liabilities 1,365 1,607
Current liabilities
Trade payables 2,894 2,543
Lease liabilities 38 94
Other liabilities 250 628
Total current liabilities 3,182 3,265
Total Liabilities 4,547 4,872
TOTAL EQUITY AND LIABILITIES 30,829 31,378
The accompanying notes are an integral part of these financial statements.
Vivoryon Therapeutics N.V.
Statements of Changes in Shareholders' Equity for the Years Ended December
31, 2023 and 2022
Accumulated
Other other
Share Share capital comprehensive Accumulated Total
in kEUR capital premium reserves loss deficit equity
January
1, 2022 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
(loss) /
income - - - 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
Net loss for
the period - - - - (28,342) (28,342)
Remeasurement
of the net
defined
benefit
pension
liability - - - (76) - (76)
Comprehensive
(loss) /
income - - - (76) (28,342) (28,418)
Proceeds from
the issuance
of common
shares 1,786 23,214 - - - 25,000
Transaction
costs of
equity
transactions - (2,095) - - - (2,095)
Share-based
payments - - 3,943 - - 3,943
Proceeds from
exercise of
share options 176 1,170 - - - 1,346
December
31, 2023 26,067 135,671 13,599 (256) (148,799) 26,282
The accompanying notes are an integral part of these financial statements.
Vivoryon Therapeutics N.V.
Statements of Cash Flows for the Years ended December 31, 2023 and 2022
in kEUR 2023 2022
Operating activities
Net loss for the period (28,342) (28,156)
Adjustments for:
Finance result (261) (758)
Depreciation and amortization 167 161
Share based payments 3,943 3,488
Capitalized capital raising costs that were expensed - 2,633
Deferred income tax (234) (199)
Reversal of Revenue and Accounts Receivable 3,095 -
Changing in
Financial assets - 3,090
Other current assets and prepayments (662) 294
Pension liabilities (94) (122)
Provisions - (35)
Trade payables 538 (1,724)
Other liabilities (17) (471)
Interest received 328 9
Interest paid (2) (4)
Cash flows used in operating activities (21,541) (21,794)
Investing activities
Purchase of plant and equipment (14) (11)
Purchase of intangible assets (500) (2)
Purchase of financial assets (19,000) -
Proceeds from sale of financial assets 9,000 -
Cash flows used in investing activities (10,514) (13)
Financing activities
Proceeds from the issuance of common shares 25,000 36,000
Transaction costs of equity transactions (2,095) (1,774)
Capital raising costs - (753)
Payment of lease liabilities (94) (92)
Proceeds from exercise of share options 1,346 -
Cash flows provided by / (used in) financing activities 24,157 33,381
Net decrease in cash and cash equivalents (7,898) 11,574
Cash and cash equivalents at the beginning of period 26,555 14,661
Effect of exchange rate fluctuation on cash held (95) 320
Cash and cash equivalents at the end of period 18,562 26,555
The accompanying notes are an integral part of these financial statements.
Annual Financial Report 2023
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 (http://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 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 (http://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 thepublished
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 Contact
Stern IR
Penelope Belnap
Tel: +1 212-362-1200
Email: penelope.belnap@sternir.com
Media Contact
Trophic Communications
Valeria Fisher
Tel: +49 175 8041816
Email: vivoryon@trophic.eu (mailto:vivoryon@trophic.eu)
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