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 (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).
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.
Corporate Development Highlights
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.
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 Statements
Statement of Operations and Comprehensive Loss for the Years Ended December 31, 2022 and 2021
|in kEUR, except for share data||2022||2021|
|Cost of Sales||—||(1,569)|
|Research and development expenses||(20,224)||(17,452)|
|General and administrative expenses||(8,908)||(4,549)|
|Other operating income||19||7|
|Result before income taxes||(28,355)||(12,223)|
|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|
|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
|Property, plant and equipment||49||66|
|Total non-current assets||684||4,291|
|Other current assets and prepayments||423||2,494|
|Cash and cash equivalents||26,555||14,661|
|Total current assets||30,694||20,229|
|Other capital reserves||9,656||6,168|
|Accumulated other comprehensive loss||(180)||(572)|
|Deferred tax liabilities||234||432|
|Total non-current liabilities||1,607||2,912|
|Total current liabilities||3,265||5,051|
|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)|
|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)|
|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
|Net loss for the period||(28,156)||(12,655)|
|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)|
|Other current assets and prepayments||191||1,852|
|Cash flows used in operating activities||(21,794)||(11,257)|
|Purchase of plant and equipment||(11)||(20)|
|Purchase of intangible assets||(2)||(8)|
|Cash flows used in investing activities||(13)||(28)|
|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 Statements
This 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:
Tel: +1 212-698-8684
Tel: +49 175 8041816