HALLE (SAALE) / MUNICH, GERMANY, September 30, 2022 – 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 reported financial results for the first six months of 2022 and provided an update on clinical and corporate progress. The report is available on the Company’s website at https://www.vivoryon.com/investors-news/financial-information/.
“The first half of 2022 was marked by decisive progress in the development of our lead candidate varoglutamstat in AD, which cumulated in several data presentations at the prestigious AAIC 2022 in San Diego in July and August,” said Dr. Ulrich Dauer, CEO of Vivoryon. “Firstly, we have been able to further de-risk clinical development of varoglutamstat with extremely encouraging safety results from our VIVIAD Phase 2b study. At the same time, adding to the preclinical data package by characterizing the additive effect of varoglutamstat in combination with anti-Abeta antibodies, we continue to explore the full potential for its application in a variety of therapeutic settings. These data, which have sparked excitement within the medical community and beyond, substantiate our commitment to making a difference to all those affected by Alzheimer’s disease. Having secured a significant private placement will enable us to continue to follow our carefully crafted development strategy. We warmly welcome our new investor KKR Dawn Aggregator L.P. and are very grateful to them and to our longstanding investor Claus Christiansen for their support through the upcoming clinical milestones.”
Portfolio Highlights (H1 2022 and post-period)
VIVIAD
VIVA-MIND
Preclinical Programs
Partnered Programs
Corporate Development Highlights (H1 2022 and post-period)
Financial Results for the First Half Year 2022
The Company generated no license revenues or smaller revenue in half year 2022 or 2021.
Research and development expenses increased in 2022 by EUR 1.6 million compared to the six months ended June 30, 2021. This increase is primarily attributable to EUR 1.7 million higher expenses related to our clinical trial VIVIAD, which has advanced significantly compared to the six months ended June 30, 2021.
General and administrative expenses for the six months ended June 30, 2022 are about the same level as for the six months ended June 30, 2021. Higher expenses for share based payments with EUR 0.3 million were compensated by EUR 0.3 million lower expenses for legal and consulting services.
Net loss for the six months ended June 30, 2022 was EUR 12.6 million, compared to EUR 11.7 million for the six months ended June 30, 2021. The Company held EUR 24.4 million in cash and cash equivalents as of June 30, 2022, compared to EUR 14.7 million as of December 31, 2021.
Cash flows provided from financing activities were EUR 19.6 million for the six months ended June 30, 2022 compared to cash used in financing activities of EUR 0.5 million in the six months ended June 30, 2021. The change mainly relates to a private placement on April 1, 2022 by way of accelerated book building, placing 2,000,000 registered shares at an offering price of EUR 10.50 per share. The Company’s issued share capital has increased to EUR 22,050,482. The gross proceeds of the offering amounted to EUR 21.0 million.
Financial Guidance
Including the proceeds from the private placement entered into on September 30, 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 December 2023. This does not include the exercise of the option to acquire up to an additional 2.054.796 shares for a period ending the later of twelve months after the date of the approval of a EU Recovery prospectus (in accordance with Section 14a Prospectus Regulation) or the achievement date of a defined clinical milestone.
Vivoryon Therapeutics N.V. Financial Statements
Condensed Statements of Profit or Loss and Other Comprehensive Income for the six months ended June 30, 2022 and 2021
For the six months ended June 30, | ||
in kEUR, except for share data | 2022 | 2021 |
Research and development expenses | (11,067) | (9,456) |
General and administrative expenses | (2,311) | (2,337) |
Other operating income | — | 5 |
Operating loss | (13,378) | (11,788) |
Finance income | 989 | 219 |
Finance expenses | (105) | (102) |
Finance result | 884 | 117 |
Result before income taxes | (12,494) | (11,671) |
Income taxes | (89) | — |
Net loss for the period | (12,583) | (11,671) |
Items not to be reclassified subsequently to profit or loss | ||
Remeasurement of the net defined benefit pension liability | 261 | — |
Total other comprehensive income / (loss) | 261 | — |
Comprehensive loss | (12,322) | (11,671) |
Loss per share in EUR (basic and diluted) | (0.60) | (0.58) |
The accompanying notes are an integral part of these condensed interim financial statements.
Vivoryon Therapeutics N.V.
Condensed Statements of Financial Position
in kEUR | June 30, 2022 | December 31, 2021 |
ASSETS | ||
Non-current assets | ||
Intangible assets | 512 | 533 |
Property, plant and equipment | 54 | 66 |
Right-of-use assets | 173 | 219 |
Financial assets | 14 | 3,473 |
Total non-current assets | 753 | 4,291 |
Current assets | ||
Financial assets | 3,812 | 3,074 |
Other current assets and prepayments | 2,795 | 2,494 |
Cash and cash equivalents | 24,383 | 14,661 |
Total current assets | 30,990 | 20,229 |
TOTAL ASSETS | 31,743 | 24,520 |
Equity | ||
Share capital | 22,050 | 20,050 |
Share premium | 101,181 | 83,211 |
Other capital reserves | 7,200 | 6,168 |
Accumulated other comprehensive loss | (311) | (572) |
Accumulated deficit | (104,883) | (92,300) |
Total equity | 25,237 | 16,557 |
Non-current liabilities | ||
Pension liability | 1,505 | 1,823 |
Provisions long-term | 12 | 12 |
Lease liabilities | 86 | 132 |
Other liabilities | — | 513 |
Deferred tax liabilities | 521 | 432 |
Total non-current liabilities | 2,124 | 2,912 |
Current liabilities | ||
Provisions | 35 | 35 |
Trade payables | 3,681 | 4,360 |
Lease liabilities | 93 | 92 |
Other liabilities | 573 | 564 |
Total current liabilities | 4,382 | 5,051 |
Total Liabilities | 6,506 | 7,963 |
TOTAL EQUITY AND LIABILITIES | 31,743 | 24,520 |
The accompanying notes are an integral part of these condensed interim financial statements.
Vivoryon Therapeutics N.V.
Statements of Changes in Shareholders’ Equity for the six months ended June 30, 2022 and 2021
The accompanying notes are an integral part of these condensed interim financial statements.
Vivoryon Therapeutics N.V.
Condensed Statements of Cash Flows
For the six months ended June 30, | ||
(in kEUR) | 2022 | 2021 |
Operating activities | ||
Result before income taxes | (12,494) | (11,671) |
Adjustments for: | ||
Finance result | (884) | (117) |
Depreciation and amortization | 81 | 82 |
Share based payments | 1,032 | 921 |
Other non-cash adjustments | 764 | (10) |
Changing in: | ||
Financial assets | 2,721 | (660) |
Other current assets and prepayments | 44 | 1,302 |
Pension liabilities | (318) | (40) |
Provisions | — | — |
Trade payables | (679) | 4,076 |
Other liabilities | (504) | 49 |
Interest received | 3 | 4 |
Interest paid | (3) | (9) |
Cash flows used in operating activities | (10,237) | (6,072) |
Investing activities | ||
Purchase of plant and equipment | (2) | (16) |
Purchase of intangible assets | — | (8) |
Cash flows used in investing activities | (2) | (24) |
Financing activities | ||
Proceeds from the issuance of common shares | 21,000 | — |
Capital raising costs | (1,374) | (468) |
Payment of lease liabilities | (46) | (45) |
Cash flows provided by / (used in) financing activities | 19,581 | (513) |
Net decrease in cash and cash equivalents | 9,342 | (6,609) |
Cash and cash equivalents at the beginning of period | 14,661 | 26,306 |
Effect of exchange rate fluctuation on cash held | 380 | 135 |
Cash and cash equivalents at end of period | 24,383 | 19,832 |
The accompanying notes are an integral part of these condensed interim financial statements.
Half Year Financial Report 2022
The condensed interim financial statements of Vivoryon have been prepared in accordance with IAS 34 Interim Financial Reporting and International Financial Reporting Standards (IFRS) of the International Accounting Standards Board, as adopted by the European Union (EU-IFRS). The half-year financial statements were not audited or reviewed. The reports are available on the Company’s website www.vivoryon.com.
Conference Call and Webcast
Vivoryon will host a conference call and webcast today, September 30, 2022, at 3:00 pm CEST (9:00 am EDT). A Q&A session will follow the presentation of the full year results.
Please dial one of the following access numbers:
From Germany: +49 (0)69 22222 5197
From The Netherlands: +31 (0)20 703 8218
From Switzerland: +41 (0)44 580 7279
From UK: +44 (0)330 165 4012
From the U.S.: +1 646 828 8143
Access Code: 8323708
Please dial in ten minutes prior to commencement.
A live webcast and slides will be made available at: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/
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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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:
Investor Contact
Vivoryon Therapeutics N.V.
Dr. Manuela Bader, Director IR & Communication
Tel: +49 (0)345 555 99 30
Email: IR@vivoryon.com
Media Contact
Trophic Communications
Valeria Fisher
Tel: +49 175 8041816
Email: vivoryon@trophic.eu