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Vivoryon Therapeutics N.V. Reports Full Year 2023 Financial Results and Provides Varoglutamstat and Strategic Updates

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Vivoryon Therapeutics N.V. Reports Full Year 2023 Financial Results and Provides Varoglutamstat and Strategic Updates

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:

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).

VIVIAD study – results from kidney function exploratory analyses

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.

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.

Early-Stage Pipeline

Vivoryon is revisiting the early-stage opportunities in its R&D activities in line with its strategic shift.

Corporate Development Updates

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/

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/

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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

in kEUR Share capital Share premium Other capital reserves Accumulated other comprehensive loss Accumulated deficit Total 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.

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 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

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